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a
- Absolute neutrophil count (ANC)The number of white blood cells in the blood that are neutrophils. A low ANC indicates neutropenia and a possible increased risk of infection.
- Accelerated ApprovalDesignation assigned to a drug by the Food and Drug Administration (FDA) intended to make promising products for life-threatening diseases available on the market on the basis of preliminary evidence prior to formal demonstration of patient benefit. In this case, clinical studies and subsequent FDA evaluation are based on a surrogate marker that is considered likely to predict patient benefit. The marketing approval that is granted may be considered provisional, and a company may be required to complete additional clinical studies that formally demonstrate patient benefit.
- Active immunotherapyType of immunotherapy that stimulates the body to mount an immune response; an example is a vaccine.
- Adhesion moleculesComplementary molecules present on cell surfaces that allow cells to interact with each other, acting in the same way as a lock and key.
- Adjuvant(1) When referring to vaccines, an adjuvant is a substance administered as part of, or along with, a vaccine that increases its effectiveness by strengthening the immune response against the vaccine. (2) Adjuvant therapy also refers to a treatment that is given in addition to a standard treatment regimen to increase its effectiveness.
- Adriamycin (doxorubicin)A type of chemotherapy which is given intravenously (into a vein). It is part of an older type of myeloma treatment called VAD. VAD consists of the combination of Vincristine (another chemotherapy drug), Adriamycin, and dexamethasone which is a steroid.
- Adverse event (AE)Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. An adverse event is a term that is a unique representation of a specific event used for medical documentation and scientific analyses. See Grade 1-4 adverse events.
- AlbuminMajor protein found in the blood. A patient’s albumin level can provide some indication of overall health and nutritional status and may also be useful in staging myeloma according to a recently proposed staging system.
- Alkeran®See Melphalan.
- Allogeneic stem cell transplantA procedure in which bone marrow or peripheral blood stem cells from a donor (usually related) are collected, stored and infused into a patient (recipient) following high-dose chemotherapy and/or radiation therapy.
- Allogeneic transplantTransplant from a human donor who is not an identical genetic match.
- AllograftAllogeneic stem cell transplant.
- Aloxi® (palonosetron)A type of medicine used to prevent or treat nausea and vomiting as a result of cancer treatment. It is given intravenously (into a vein).
- Alpha interferonCytokine produced by T cells that exhibits a variety of immunomodulating effects, including suppression of cell growth and enhancement of tumor cell killing.
- Amyloid proteinFiber-like substance, often composed of light chains and other proteins, that can accumulate in and damage various tissues and organs.
- AmyloidosisCondition related to multiple myeloma whereby a patient’s light chains can clump together to form insoluble protein fibers known as amyloid fibrils. Amyloid fibrils can accumulate in various tissues and organs, disrupting their normal functions. Rarely, patients with myeloma may also develop amyloidosis.
- AnemiaDecrease in the number of red blood cells in the blood.
- AngiogenesisGrowth of new blood vessels.
- AnthracyclineClass of anticancer drugs that includes doxorubicin (Adriamycin®) and related compounds such as daunorubicin and daunomycin.
- AntibodyProtein produced by a plasma cell that is generated in reaction to a foreign protein (antigen), thus producing an immunity against that protein; also known as an immunoglobulin.
- AntigenSubstance that stimulates the production of an antibody to which it subsequently binds.
- Anzemet® (dolasetron)A type of medicine used to prevent or treat nausea and vomiting as a result of cancer treatment. It is given intravenously (into a vein).
- ApheresisProcedure in which blood is taken from a donor, a blood component (such as white blood cells, red blood cells or plasma) is separated out, and the remaining blood components are reinfused back into the donor.
- ApoptosisProgrammed (natural) cell death.
- AstheniaMarked loss of body strength.
- AutograftAutologous stem cell transplant.
- Autoimmune diseasesIllnesses that occur when the body tissues are attacked by its own immune system.
- AutologousFrom the patient. In myeloma, this term usually refers to a commonly used type of stem cell transplantation where the patient serves as their own donor.
- Autologous peripheral blood stem cell transplantsA type of stem cell transplantation where the patient’s own stem cells are used. In this type of transplant, stem cells are collected from the circulating blood (peripheral blood). Autologous peripheral blood stem cell transplants are the most common type of stem cell transplants performed today.
- Autologous stem cell transplantProcedure in which a patient’s own stem cells from the bone marrow or peripheral blood are collected, stored and reinfused following high-dose chemotherapy and/or radiation therapy.
- Autologous transplantTransplant whereby the patient’s own cells or tissues are collected and reinfused or transplanted.
b
- B cellWhite blood cell that gives rise to a plasma cell after being exposed to a foreign substance; also called a B lymphocyte.
- B lymphocyteSee B cell.
- Basic fibroblast growth factor (bFGF)Growth factor that promotes angiogenesis (the growth of new blood vessels); also known as FGF-2.
- Bcl-2Protein made by cancer cells that is thought to block chemotherapy-induced cell death.
- Bence-Jones proteinSee Light chain.
- Beta 2-microglobulin (ß2-microglobulin or ß2-M)Protein normally found on the surface of various cells in the body. Increased serum levels can occur in patients with myeloma or kidney disease. Lower levels are associated with a more favorable prognosis in myeloma.
- Biaxin (clarithromycin)Type of antibiotic.
- BisphosphonateType of drug used to treat osteoporosis and bone disease in cancer patients. Bisphosphonates work by inhibiting the activity of bone-destroying cells called osteoclasts.
- Bladé CriteriaSet of stringent, standardized criteria developed by members of the European Group for Blood and Marrow Transplant (EBMT), International Bone Marrow Transplant Registry (IBMTR), and Autologous Blood and Marrow Transplant Registry (ABMTR) that are increasingly being used to measure response to therapy in myeloma clinical trials (Bladé et al. Br J Haematol. 1998;102(5):1115-1123.) The criteria include two assessments of M protein levels, percent plasma cells in the bone marrow and skeletal disease performed at least 6 weeks apart.
- Blood urea nitrogen (BUN)Byproduct of protein metabolism that is normally filtered out of the blood and found in the urine. Elevated levels in the blood can indicate decreased kidney function.
- Bone marrowSoft, spongy tissue found in the center of many bones where blood cells are produced.
- Bone marrow aspirationRemoval of fluid and cells of the bone marrow via use of a needle.
- Bone marrow biopsyRemoval of bone marrow tissue via the use of a needle.
- Bone marrow transplantProcedure in which stem cell-containing bone marrow is collected, stored and infused following high-dose chemotherapy and/or radiation therapy. These are rarely done in multiple myeloma.
- Bone remodelingProcess of normal bone maintenance whereby old, worn-out bone is broken down and removed by osteoclast cells and new bone is formed by osteoblast cells.
- Bone resorptionThe normal process of breaking down of bone by osteoclasts during bone remodeling. Bone resorption can be increased in myeloma.
- Bone (skeletal) surveySeries of X-rays of the skull, spine, arms, ribs and legs.
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- C-reactive protein (CRP)Protein produced by the liver when there is an inflammatory process occurring in the body. Serum levels of CRP are increased in various inflammatory diseases, degenerative diseases and cancers, including myeloma. Lower levels are associated with a more favorable prognosis in myeloma.
- CalciumMineral important in bone formation. Elevated serum levels occur when there is bone destruction.
- CatheterA thin flexible tube that is inserted into the body. For example, it may be inserted into a vein in order to give drugs, blood or nutrients. Catheters are also used to take blood or empty the bladder.
- CD34+Cell surface marker. CD stands for cluster of differentiation and the 34+ indicates a specific antigen for which this cell is positive. Stem cells are CD34+.
- Chemistry profileBlood test that determines levels of several chemical compounds in the blood at one time. Of particular importance in myeloma are levels of blood urea nitrogen (BUN), calcium, creatinine and lactate dehydrogenase (LDH).
- ChemobrainConstellation of symptoms, such as loss of memory, difficulty with language and lack of concentration, that have been reported by cancer patients who receive chemotherapy; also known as cognitive dysfunction.
- ChemotherapyThe use of drugs to treat cancer.
- ChromosomeA structure in cells composed of condensed DNA (which contains the genes).
- Chromosome analysis (cytogenetic testing)Laboratory test that measures the number and normalcy of chromosomes; also known as cytogenetic testing.
- Chromosome DeletionIn some individuals with multiple myeloma, a piece of one or more of certain chromosomes may be missing (or deleted). A deletion in certain chromosomes may indicate a more aggressive form of myeloma.
- Colony-stimulating factor (CSF)Protein that stimulates the development and growth of blood cells; sometimes called growth factor. Granulocyte colony-stimulating factor is a CSF that is used to mobilize stem cells from the bone marrow into the bloodstream prior to apheresis.
- Complete blood count (CBC)Blood test that measures the number of red blood cells, white blood cells, and platelets in the blood and the relative proportions of the white blood cells present.
- Complete remissionSee complete response
- Complete response (CR)A treatment outcome where there are ≤5% plasma cells in the bone marrow and no evidence of myeloma proteins in the serum or urine as measured by standard laboratory techniques.
- Computed tomography (CT)Imaging technique that uses a computer to generate 3-dimensional X-ray pictures; also known as computerized axial tomography (CT).
- Computerized axial tomography (CAT)See Computed tomography (CT).
- Conditioning regimenCombination of chemotherapy and/or radiation treatments administered over a period of several days prior to stem cell transplantation in order to kill cancer cells.
- Consolidation TherapyAnti-myeloma treatment given after the initial therapy in order to further reduce the number of cancer cells.
- Conventional chemotherapyAdministration of chemotherapy at a dose that does not completely destroy the bone marrow; also known as standard-dose chemotherapy.
- Cord blood transplantType of transplant where the stem cells are obtained from the umbilical cord and placenta (afterbirth) following the delivery of a baby. These cells are frozen for future use.
- CorticosteroidPotent class of drugs that has anti-inflammatory, immunosuppressive and antitumor effects. Dexamethasone and prednisone are examples of corticosteroids.
- Coumadin® (also known as warfarin)A pill that is a type of blood thinner. It is used to prevent blood clots.
- CRSee complete response
- CreatinineProduct of energy metabolism of muscle that is normally filtered out of the blood and found in the urine. Elevated levels in the blood can indicate decreased kidney function.
- CryoglobulinemiaCondition that occurs when a myeloma protein is of a specific type that comes out of solution as particles when exposed to cold temperatures. These particles may block small blood vessels and cause symptoms such as pain and numbness in the fingers and toes in cold weather.
- CryopreservationA method of freezing cells that permits storage over an extended period.
- CureTreatment outcome where there is complete and lasting recovery from disease. This has not yet been achieved in myeloma.
- Cutaneous T-cell lymphoma (CTCL)A type of non-Hodgkin’s lymphoma which is a cancer of the immune system.
- Cyclooxygenase-2 (COX-2)A protein that acts as an enzyme to enhance the production of prostaglandins responsible for promoting inflammation.
- CyclophosphamideType of chemotherapy. Brand names include Cytoxan® and Neosar®.
- CyclosporineImmunosuppressive drug used following allogeneic transplants that helps prevent graft-versus-host disease (donor cells attacking the recipient’s cells).
- Cytogenetic testingSee Chromosome analysis.
- CytokineSoluble factor produced by cells that influences other cells.
- Cytoxan®See Cyclophosphamide.
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- Decadron® (dexamethasone)Type of corticosteroid used in the treatment of myeloma. Decadron is part of many combination chemotherapy regimens.
- Deep vein thrombosis (DVT)Serious condition where a blood clot forms in one of the deep veins in the body, usually in the legs or lower abdomen. DVT is treated with a blood thinner (also called an anticoagulant).
- Dendritic cellImmune cell that plays an important role in initiating and regulating immune responses.
- DexamethasoneA steroid used in the treatment of multiple myeloma, often in combination with another anti-myeloma drug. Decadron® is one brand of dexamethasone.
- Disease-free survivalThe length of time during and after treatment in which a patient is living with a disease that does not get worse; also referred to as progression-free survival (PFS).
- Disease statusWhether a patient has already received therapy for their myeloma disease and if so, what was the outcome.
- DMSODimethyl sulfoxide, a colorless chemical used for cryopreservation of stem cells. When introduced into the body, may cause unpleasant or even serious toxic effects.
- DNA (deoxyribonucleic acid)Genetic material of the cell located in the chromosomes.
- Donor Lymphocyte Infusion (DLI)Experimental therapy used following high-dose chemotherapy and allogeneic stem cell transplant; involves the administration of additional immune cells from the same allogeneic donor to help attack myeloma cells and control the disease.
- Doxil® (doxorubicin HCl liposome injection)A chemotherapy drug used in cancer treatment. It is a reformulated version of doxorubicin (Adriamycin®), a cancer drug that was used for many years in traditional chemotherapy regimens, including VAD (vincristine, Adriamycin, and dexamethasone) in myeloma.
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- ElectrolytesElectrolytes are minerals that are present in the body such as sodium, potassium, chloride and bicarbonate. The balance of electrolytes is essential for the normal function of organs. Diarrhea may cause electrolyte depletion.
- Electrophoresis (EP)Laboratory test used to measure the levels of various proteins in the blood or urine. Uses an electrical current to sort proteins by their molecular size and charge.
- Emend® (aprepitant)A type of medicine used to prevent or treat nausea and vomiting as a result of cancer treatment. It may be given either orally or intravenously (into a vein).
- Emerging therapyNew treatment that is being investigated in clinical trials.
- Endothelial cellType of cell that lines blood vessels.
- EngraftmentProcess in which stem cells in transplanted bone marrow or blood migrate to the bone marrow and begin to grow and produce new white blood cells, red blood cells and platelets.
- EnteritisStomach pain or cramps caused by an inflammation of the small intestine.
- ErythropoiesisThe production of red blood cells by the bone marrow.
- ErythropoietinGrowth factor that stimulates the bone marrow to produce red blood cells.
- EsophagitisHeartburn caused by an irritated esophagus (tube leading from the mouth to the stomach).
- Event-free survival (EFS)Term used in oncology clinical trials to denote the length of time that a patient remains free of certain negative events, such as cancer recurrence or progression, complications from the disease or death from any cause. The specific events, as well as when timing begins, may vary from trial to trial.
- Expanded accessRefers to any of the procedures initiated by the Food and Drug Administration (i.e., compassionate use, parallel track and treatment IND) that distributes experimental drugs to patients who are failing on currently available treatments for their condition and are unable to participate in ongoing clinical trials.
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- Farydak® (Panobinostat)Farydak® is a histone deacetylase inhibitor that is administered in combination with Velcade® (bortezomib) and dexamethasone. It is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including Velcade and an immunomodulatory agent. This indication was approved by the FDA on February 23, 2015, under accelerated approval based on progression-free survival.
- Fast Track designationStatus assigned by the Food and Drug Administration (FDA) to a drug or product in clinical trials signifying that the FDA will facilitate and expedite the development and review of the application for the approval of the new drug. Fast track status is usually reserved for drugs that are intended for the treatment of serious or life-threatening conditions and which demonstrate the potential to address an unmet medical need.
- Febrile neutropeniaPresence of a low neutrophil count in the blood that is associated with fever; may indicate the presence of infection (that may be serious or life-threatening).
- Fibroblast growth factor 2 (FGF-2)Growth factor that promotes angiogenesis (the growth of new blood vessels); also known as basic fibroblast growth factor (bFGF).
- FilgrastimA type of growth factor that stimulates the growth of white cells in the bone marrow; also known as G-CSF (granulocyte colony stimulating factor) or Neupogen™.
- Fluorescence in situ hybridization (FISH)Type of chromosome analysis that detects abnormalities of specific chromosomes.
- FluoroscopeType of X-ray that allows viewing of bone.
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- Grade 1 Adverse Event (AE)A mild side effect resulting from a medical therapy. Minimal or no symptoms may be present and typically medical intervention is not required.
- Grade 2 AEA moderate side effect resulting from a medical therapy. Depending on the nature of the side effect, medical intervention may or may not be needed.
- Grade 3 AEA severe side effect resulting from a medical therapy. This side effect typically interferes with patient functioning and requires medical intervention.
- Grade 4 AEA life-threatening or disabling side effect resulting from a medical therapy. Immediate medical intervention is required.
- Graft-versus-host disease (GVHD)Complication of allogeneic transplants resulting from donor immune cells recognizing the recipient’s cells as foreign and mounting an attack against them.
- Graft-versus-myeloma effectBeneficial effect of allogeneic transplants resulting from the donor cells mounting an attack on the recipient’s myeloma cells.
- GranulocyteType of white blood cell important in fighting infection. Neutrophils are the most abundant type of granulocyte.
- Granulocyte colony-stimulating factor (G-CSF)A drug that stimulates the production of infection-fighting white blood cells known as granulocytes. G-CSF is used to help prevent low white blood cell counts and infection in patients receiving chemotherapy and/or stem cell transplants and is also used to help mobilize stem cells prior to stem cell transplant. In addition, it may be used to stimulate white blood cell production in patients whose white blood cell levels drop as a side effect of an anti-myeloma treatment.
- Granulocyte-macrophage colony-stimulating factor (GM-CSF)A drug that may be used as an alternate to G-CSF (see above). It stimulates the production of infection-fighting white blood cells known as granulocytes and macrophages. Similar to G-CSF, GM-CSF is used to help prevent low white blood cell counts and infection in patients receiving chemotherapy and/or stem cell transplants and is also used to help mobilize stem cells prior to stem cell transplant.
- Growth factorsDrugs that are used to stimulate the production of certain types of cells. The most commonly used growth factors are red blood cell growth factors (also known as erythropoietin) and white blood cell growth factors (also known as colony stimulating factors or CSFs).
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- Hand-foot syndrome (HFS)Skin condition noted by tingling or burning, redness, flaking, bothersome swelling, small blisters or small sores on the palms of the hands or soles of the feet. HFS is a common side effect of certain types of chemotherapy, such as doxorubicin and liposomal doxorubicin (Doxil), and is also known as palmar-plantar erythrodysesthesia (PPE).
- Heavily pre-treatedRefers to patients who have recently had several prior therapies for their disease.
- Heavy chainThe longer of the two protein chains that make up an immunoglobulin molecule.
- HematocritA laboratory test used to determine if anemia is present; refers to the percentage of the volume of a blood sample that consists of red blood cells.
- HematologicPertaining to the blood.
- HematopoiesisFormation and development of blood cells in the bone marrow.
- Hematopoietic stem cellsCells found in the bone marrow or the circulating blood that are responsible for the production of other blood cells.
- HemoglobinA substance found within red blood cells that carries oxygen from the lungs to the tissues in the body. Low hemoglobin levels are an indicator of anemia.
- HeparanaseEnzyme produced by tumor cells that promotes angiogenesis by loosening the “glue” that holds cells of blood vessel walls together. This, in combination with angiogenic growth factors, allows the sprouting of new blood vessels.
- HeparinA type of blood thinner used to prevent blood clots. It is given as an injection. Some types may be self-administered by patients at home.
- Hepatic impairmentReduced liver function that is noted by increased levels of various substances in the blood, such as bilirubin.
- High-dose chemotherapyAdministration of very high doses of chemotherapy that may be more effective in eliminating myeloma cells than standard treatments. High-dose chemotherapy destroys the bone marrow, which is responsible for the production of blood cells. After high-dose chemotherapy, a procedure called stem cell transplant is required to replenish blood-forming bone marrow cells.
- High risk myelomaA type of myeloma where there is some feature that indicates a worse prognosis. For example, certain types of abnormalities in the DNA are associated with more aggressive disease. In addition, elevated blood levels of a protein called beta 2-microglobulin are also associated with worse prognosis.
- HypercalcemiaCondition noted by elevated levels of calcium in the blood due to increased bone destruction.
- Hypercalcemia of malignancy (HCM)Condition occurring in various forms of cancer noted by elevated levels of calcium in the blood due to increased bone destruction; also known as tumor-induced hypercalcemia (TIH).
- Hyperviscosity syndromeCondition that can occur in myeloma whereby the protein concentration in the blood becomes very high and the blood becomes very thick and sticky. Symptoms can include shortness of breath, confusion, and chest pain.
- HypothyroidismCondition where the thyroid gland is less active than normal, resulting in symptoms such as a low metabolic rate and lack of energy.
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- Immune responseReaction occurring within the body to defend against foreign invaders.
- Immune systemNetwork of related cells, tissues and organs that protect the body from disease organisms, other foreign bodies and cancers.
- ImmunoelectrophoresisSee Immunofixation electrophoresis.
- Immunofixation electrophoresis (IFE)Type of electrophoresis that uses a special antibody staining technique to identify specific types of immunoglobulin and light chains; also called immunoelectrophoresis.
- ImmunoglobulinProtein produced by a plasma cell that is generated in reaction to a foreign protein (antigen), thus producing an immunity against that protein; also known as an antibody. Immunoglobulins are made up of 2 heavy chains and 2 light chains that form a “Y”-like structure and can be of the IgA, IgD, IgE, IgG or IgM class.
- Immunomodulatory agentDrug that affects, enhances or suppresses the immune system.
- Immunomodulatory drugs or IMiDs®Drugs that work to fight cancer cell growth by impacting the functioning of the immune system.
- Immunosuppressive drugDrug given to suppress a patient’s immune system, such as one given to prevent rejection of transplanted tissue.
- ImmunotherapyThe treatment of, or prevention against, a disease achieved through manipulation of the patient’s immune system.
- Induction therapyInitial therapy for myeloma. This term also refers to the use of anti-myeloma drugs prior to high-dose chemotherapy and stem cell transplant in order to reduce the tumor burden.
- Infusion ReactionPossible side effect seen with some drugs that are given intravenously. Symptoms are usually mild to moderate and most commonly include chills, fever, nausea, weakness, headache, skin rash and/or itching. In most cases, these reactions can be managed by either slowing or stopping the infusion. Although rare, severe reactions such as difficulty breathing or low blood pressure may occur which require treatment.
- Institutional Review Board (IRB)Board designed to oversee the research process in order to protect participant safety. Made up of researchers, ethicists and lay people from the community, the board must review clinical trial protocols and the informed consent forms participants sign.
- Interferon (IFN)Substance naturally produced in the body by virus-infected cells that protects noninfected cells from viral infection. Interferon also has various effects on the immune system and is used in the treatment of several cancers and infectious diseases.
- Interleukin 1 beta (IL-1b)Cytokine that enhances the growth and survival of B cells and myeloma cells and promotes inflammation.
- Interleukin 10 (IL-10)Cytokine involved in the growth and survival of myeloma cells.
- Interleukin 12 (IL-12)Cytokine that promotes T cell function and tumor cell killing.
- Interleukin 2 (IL-2)Cytokine (growth factor) produced by T-cells that stimulates the growth of T cells and B cells.
- Interleukin 4 (IL-4)Cytokine that enhances the immune system’s ability to fight tumor cells.
- Interleukin 5 (IL-5)A potent T-cell derived factor that stimulates the growth of B-cells.
- Interleukin 6 (IL-6)Cytokine that promotes the growth and survival of myeloma cells and normal B cells.
- Interleukin 8 (IL-8)Cytokine secreted by bone marrow stromal cells in myeloma patients that promotes formation of osteoclasts (bone degrading cells).
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- Kepivance® (palifermin)Medication that is used to protect against the development of mouth sores that are a side effect of high-dose chemotherapy. It may also reduce the duration and severity of mouth sores if they do occur.
- KyphoplastyProcedure used to treat spinal compression fractures whereby a balloon is inserted into the compressed vertebra and inflated to elevate the collapsed section. The cavity is filled with bone cement, stabilizing and preserving the re-established height.
- Kyprolis™A new type of proteasome inhibitor. It is in the same class of drugs as Velcade.
- Kytril® (granisetron)A type of medicine used to prevent or treat nausea and vomiting as a result of cancer treatment. It is taken orally.
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- Lactate dehydrogenase (LDH)Enzyme found in body tissues. Elevated blood levels occur when there is tissue damage and may occur in myeloma, where they reflect tumor-cell burden.
- Leukine® (sargramostim)A brand of Granulocyte colony-stimulating factor (G-CSF) that stimulates the growth of white blood cells in the bone marrow.
- Light chainThe shorter of the two protein chains that make up an immunoglobulin molecule. May be of the kappa or lambda type. Light chains produced by myeloma cells are also referred to as Bence-Jones proteins.
- LiposomeBubble- or onion-like particle made out of lipids (fats) that is used to encapsulate drugs. Encapsulation helps the drug remain in the body for a longer period of time and may reduce toxicity.
- LymphocyteSmall white blood cell essential for normal function of the immune system; may be 1 of 2 types: a T lymphocyte or B lymphocyte.
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- Magnetic resonance imaging (MRI)Imaging technique that uses magnetic energy to provide detailed images of bone and soft tissue.
- Maintenance therapyTreatment that is given to patients in remission over a long period of time, in order to reduce the risk of relapse.
- MalignantCancerous, continuing to divide.
- Marketing Authorization Application (MAA)Compilation of information on the safety and efficacy of a new drug that is submitted to the European regulatory agency in order to request approval to market the drug as therapy for a particular disease indication; similar to a New Drug Application (NDA), which is submitted in the United States.
- Matrix metalloproteinases (MMPs)Enzymes that break down the structure of connective tissue.
- MelphalanType of chemotherapy often used in the treatment of myeloma (also known as Alkeran®).
- MetastasisThe spread of tumor cells from the initial site to other areas of the body.
- Microvascular density (MVD)Measure of the number of blood vessels in the bone marrow as an indication of the degree of angiogenesis (growth of new blood vessels). A value of less than 6 blood vessels per field when viewing bone marrow cells at 400x magnification is associated with a more favorable prognosis.
- Mini-allogeneic transplantType of allogeneic stem cell transplant that uses lower doses of chemotherapy and thus does not completely destroy the bone marrow; also known as mini-transplant or non-myeloablative transplant.
- Mini-transplantSee mini-allogeneic transplant.
- Minimal residual disease (MRD)The amount of myeloma cells remaining after a course of treatment, as measured by very sensitive testing; can be as low as one myeloma cell in 1 million normal cells.
- Minimal responseTreatment outcome where there is less than 50% decrease in M protein; also known as minor response. Some myeloma groups consider minimal response to be part of the definition of stable disease.
- MobilizationAdministration of colony-stimulating factors or chemotherapy to help move stem cells from the bone marrow into the blood stream to increase the number of peripheral blood stem cells collected for a stem cell transplant.
- Monoclonal antibodyType of man-made antibody that is used in the diagnosis and treatment of various diseases. All monoclonal antibodies of a specific type are identical to each other.
- Monoclonal gammopathy of undetermined significance (MGUS)Precancerous and asymptomatic condition noted by the presence of M protein in the serum or urine. MGUS may progress to myeloma.
- Monoclonal (M) proteinA type of protein made by myeloma cells, used to estimate the extent of myeloma disease. It is an abnormal type of antibody (or immunoglobulin) and is found in the blood or urine. M protein levels are used to determine the effectiveness of myeloma treatments.
- Monocyte/MacrophageType of white blood cell important in the immune response.
- MorphologyOverall appearance.
- MPA therapy consisting of the combination of melphalan, a chemotherapy drug, and prednisone, a steroid. MP has been used in myeloma treatment for many years. Today, it is usually given in combination with one of the newer agents, such as Revlimid, Velcade or Thalomid.
- MucositisInflammation of mucous membranes lining the digestive tract; a common and painful side effect of intensive chemotherapy or radiotherapy that can result in sores and infection.
- Mycophenolate mofetil (CellCept®)Immunosuppressive drug used following allogeneic transplants that helps prevent graft-versus-host disease (donor cells attacking the recipient’s cells).
- MyeloablationThe killing of bone marrow by radiation or chemotherapy. This term usually refers to the complete or near-complete destruction of the bone marrow.
- Myelodysplastic syndrome (MDS)A group of diseases that affect the blood. It is not related to multiple myeloma.
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- Natural killer (NK) cellType of white blood cell important in killing tumor cells.
- Near complete response (near CR)Response to therapy where M protein is no longer detectable in the blood and/or urine using conventional tests, but is detectable with the more sensitive immunofixation test, and there are less than 5% plasma cells in the bone marrow.
- NephrotoxicityToxicity to the kidneys.
- Neuropathic PainChronic pain caused by damage to, or dysfunction of, nerves.
- NeuropathyDisorder of the nerves that can result in abnormal or decreased sensation or burning/tingling. When the hands and feet are affected, it is referred to as peripheral neuropathy.
- NeutropeniaBelow-normal number of neutrophils.
- NeutrophilType of white blood cell that plays an important role in the immune system (e.g., can destroy bacteria).
- New Drug Application (NDA)Compilation of information on the safety and efficacy of a new drug that is submitted to the U.S. Food and Drug Administration (FDA) in order to request approval to market the drug as therapy for a disease indication.
- Newly diagnosed diseaseMultiple myeloma that has not yet been treated.
- Non-myeloablative allogenic transplantSee mini-allogeneic transplant
- Nonsecretory myelomaRare form of myeloma affecting about 1% of myeloma patients where the malignant plasma cells do not secrete M protein or light chains.
- Nonsteroidal anti-inflammatory drugs (NSAIDs)Common types of painkillers. There are both over-the-counter NSAIDs as well as prescription NSAIDs. Examples of over-the-counter NSAIDs include aspirin, Motrin® (ibuprofen) and Aleve® (naproxen)
- Novel erythrocyte stimulating protein (NESP)Protein that stimulates the bone marrow to produce red blood cells.
- Nuclear factor ?B (NF-?B)Key survival protein found within the cell that acts as a messenger. When a cell receives an external signal, such as a growth factor, NF-kB transfers the message to the nucleus of the cell, causing some type of response, such as cell growth.
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- Office for Human Research Protections (OHRP)Government office that safeguards participants in federally funded research and provides unity and leadership for many federal departments and agencies that carry out research involving human participants.
- Orphan DrugTerm referring to a product that treats a rare disease affecting fewer than 200,000 Americans. The Food and Drug Administration (FDA) provides this designation and incentives for companies making orphan drugs to stimulate the research, development and approval of products that treat rare diseases.
- OsteoblastBone-forming cell.
- OsteoclastBone-destroying cell that works in conjunction with bone-forming cells to repair bone.
- Osteoclast-activating factor (OAF)Substance released by tumor cells that promotes the activity of bone-destroying osteoclasts. Examples of OAFs include parathyroid hormone-related peptide (PTHrP), growth factors and cytokines.
- Osteolytic lesionSoft spot in the bone where bone tissue has been destroyed. The lesion appears as a hole on a standard bone X-ray.
- OsteonecrosisDeath or destruction of bone tissue due to trauma, loss of blood supply or disease.
- OsteopeniaA condition where bones are thinner than normal, but the bone loss is not severe enough to be classified as osteoporosis.
- OsteoporosisGeneralized bone loss typically associated with old age.
- Overall response rate (ORR)Typically the percentage of patients who respond to a specific therapy in a clinical trial with a partial response or better.
- Overall survival (OS)Term used in oncology clinical trials to denote the length of time a patient survives.
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- Paget’s DiseaseA bone disease that is not related to cancer. It is a chronic condition that results in enlarged and deformed bones.
- PaliferminMedication that stimulates the growth of cells found in the oral cavity and skin and reduces the duration and severity of oral mucositis (inflammation of the lining of the digestive tract) after intensive chemotherapy and radiotherapy for hematologic cancers. The brand name for palifermin is Kepivance™.
- PalliativeMeant to reduce symptoms and relieve pain rather than to alter the course of disease.
- Palmar-plantar erythrodysesthesia (PPE)See hand-foot syndrome (HFS)
- Pamidronate (Aredia®)A type of bisphosphonate. Bisphosphonates are drugs that are used to treat osteoporosis as well as to prevent and treat bone problems in myeloma patients.
- ParaproteinSee Monoclonal protein.
- Parathyroid hormone-related peptide (PTHrP)Hormone produced by certain tumors that promotes the activity of bone-destroying osteoclasts and causes increased calcium in the blood (hypercalcemia).
- Partial response (PR)Treatment outcome where there is a greater than 50% decrease in M protein; also referred to as partial remission.
- PegylatedWhen a polyethylene glycol molecule is added on to a drug molecule. Pegylation helps a drug remain in the body for a longer period of time.
- Performance statusA measure of a patient’s ability to perform everyday functions and self-care.
- Peripheral bloodThe blood that circulates throughout the body.
- Peripheral blood stem cell (PBSC)Stem cells collected from the blood. The term “peripheral” means that the cells come from outside the bone marrow.
- Peripheral blood stem cell (PBSC) transplantProcedure in which blood containing mobilized stem cells is collected by apheresis, stored and infused following high-dose chemotherapy and/or radiation therapy.
- Peripheral neuropathyDisorder of the nerves that can result in abnormal or decreased sensation or burning/tingling in the hands and feet.
- Phase I/II StudyA clinical study that combines a Phase I and a Phase II trial of the same treatment. First, the Phase I part of the trial determines a safe dose, then more patients are treated at this dosage in the Phase II part of the study to further evaluate safety and efficacy.
- Phase I StudyAn early, small clinical study which is used to determine a drug’s safety and dosage levels in humans.
- Phase II StudyPhase of clinical testing where a new treatment is evaluated for activity. In cancer trials, the new treatment will be tested against a certain type of cancer.
- Phase III studyA large clinical study (or trial) conducted in order to determine the effectiveness and safety of new treatments. Usually, the new treatment is compared to an established treatment (not placebo).
- Phase IV studyClinical study conducted after a drug is approved by the Food and Drug Administration (FDA); may be conducted at the request of the FDA or by the sponsoring company for various reasons. Phase IV studies may involve a larger patient population than that studied during earlier clinical trials; they help monitor the safety of the drug and provide ongoing technical support.
- PlaceboDrug or treatment that is designed to look like the medicine being tested but doesn’t have the active ingredient. Placebos are very rarely used in cancer treatment trials.
- Plasma cellA type of white blood cell that normally makes up about 5% of all cells found in bone marrow. As part of the immune system, they combat infection by producing disease-fighting proteins called immunoglobulins, or antibodies. When foreign substances — or antigens — enter the body, plasma cells develop from a type of white blood cell called B cells. In response to invasion by antigens, groups of plasma cells produce antibodies to fight off disease and infection. Each plasma cell develops in response to a particular antigen and produces antibodies specific to it, resulting in millions of different antibodies being available to fight invaders in each patient.
- PlasmablastImmature plasma cell.
- Plasmablastic morphologyWhen the shape and appearance of myeloma cells are more similar to that of early immature plasma cells (plasmablasts). Absence of plasmablastic morphology typically indicates a more favorable prognosis.
- PlasmacytomaSingle tumor composed of malignant plasma cells that occurs in bone or soft tissue. Patients with a plasmacytoma may develop myeloma.
- PlasmapheresisProcedure in which blood is taken from a donor, the plasma is separated out and the remaining blood cells are reinfused back into the donor; fluids are sometimes administered to replace the removed plasma. In myeloma patients, this technique may be used to remove excess monoclonal protein in the blood.
- Plateau phaseWhen the outcome of therapy, be it a response or stable disease, has leveled off and disease parameters remain at a stable level.
- PlateletsSmall cell fragments in the blood that help blood clotting.
- Pomalyst (pomalidomide)A type of immunomodulatory drug. It is in the same class of drugs as Revlimid and Thalomid.
- Precursor cellEarlier form of a cell; for example, B cells are precursors of plasma cells.
- PrednisoneType of steroid used to treat myeloma. It is frequently given in combination with a chemotherapy drug called melphalan.
- Priority ReviewDesignation assigned to a drug or product by the Food and Drug Administration (FDA) stating that the FDA will review the application for approval within a target date of 6 months rather than the standard review target date of 10 months. A Priority designation is intended for drugs and products that address unmet medical needs.
- PrognosisThe forecast or likely outcome of a disease. A patient’s prognosis is usually based on the extent of disease as noted by the existence of different signs, symptoms and circumstances, and clinical or laboratory findings.
- Prognostic indicatorClinical or laboratory finding that helps determine prognosis. In myeloma, a prognostic indicator may help determine how fast the tumor is growing, the extent of disease, tumor cell biology, response to therapy, overall health status of the patient and when treatment should begin.
- Progression-free survival (PFS)The length of time during and after treatment in which a patient is living with a disease that does not get worse; also referred to as disease-free survival.
- Progressive diseaseActive myeloma that is worsening (i.e., increasing M protein and worsening end organ damage). In most cases, relapsed and/or refractory disease can be considered to be progressive disease.
- ProteasomeComplex of enzymes found within cells that play a key role in the regulation of cell function and growth. Proteasomes break down and clear out proteins after they’ve done their job and are no longer needed. Myeloma cells appear to be particularly dependent on proteasomes to grow and survive, and they can undergo programmed cell death (apoptosis) if proteasome activity is blocked by a proteasome inhibitor such as Velcade, Kyprolis or Ninlaro.
- ProtocolAction plan for a clinical trial that includes detailed description of patients who may join the trial, the therapy that will be given and the care the patients will receive during and after the trial.
- Pulmonary embolismA sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from a vein in the leg. This is a very serious condition which may be life-threatening.
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- RadiopharmaceuticalA radioactive drug used for diagnostic or therapeutic purposes.
- RadiotherapyRadiation therapy; the use of high-energy particles or rays to damage cancer cells and prevent them from growing.
- RandomizationMethod used to prevent bias in research studies; a computer or a table of random numbers generates treatment assignments, and participants have an equal chance to be assigned to one of two or more groups (e.g., the control group or the investigational group).
- RANK L (also known as RANK Ligand)Substance produced by bone marrow stromal cells and bone-forming osteoblasts that induces the development and growth of osteoclasts and contributes to the bone disease of myeloma. RANK L is blocked by Xgeva, a monoclonal antibody therapy approved in myeloma, that reduces skeletal related events.
- Red blood cell (RBC)Oxygen-transporting blood cell.
- Refractory diseaseMyeloma that does not respond to the first therapy given and the number of myeloma cells continues to increase despite treatment.
- Relapsed diseaseMyeloma disease that initially responded to therapy but then begins to progress again.
- RemissionPeriod during which no evidence of disease is present.
- Renal ImpairmentReduced kidney function. A type of protein called creatine, found in the blood, is used to monitor kidney function.
- ResponseA decrease in the amount of myeloma cells as a result of treatment. Response is commonly measured by the amount of M protein in the blood or urine.
- Response Rate or Overall ResponseThe total percentage of patients who respond to a specific therapy in a clinical trial.
- Responsive diseaseMyeloma that is responding to therapy with a decrease in M protein of at least 50%. Some myeloma groups consider a decrease in M protein between 25% and 50% to be a minimal response.
- Revlimid® (lenalidomide)Oral drug with multiple anti-myeloma effects. Revlimid has been shown to be effective in newly diagnosed and relapsed or refractory myeloma alone and in combination with other drugs. It is chemically similar to an older myeloma drug called Thalomid® (thalidomide).
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- Salvage therapySecond-line therapy; used to treat disease that has not responded to initial therapy or relapsed disease.
- Serum protein electrophoresis (SPEP)Test used to measure the levels of various proteins in the blood or serum. Uses an electrical current to sort proteins by their charge and size.
- Smoldering multiple myeloma (SMM)Type of asymptomatic myeloma representing about 5% of cases and noted by monoclonal protein and slightly increased numbers of plasma cells in the bone marrow. Patients with SMM are monitored and currently only treated if their disease progresses.
- Special Protocol Assessment (SPA)Procedure by which the U.S. Food and Drug Administration (FDA) evaluates and provides guidance on proposed protocols for pivotal Phase III clinical trials. The SPA provides the trial sponsors with a binding written agreement that the design and analysis of the study are adequate to support an application submission if the study is performed according to the SPA.
- Stable disease (SD)Treatment outcome where the disease has not responded to therapy but has not progressed. It also refers to disease that initially responded to therapy and remains stable after treatment is stopped.
- Stage I diseaseMyeloma disease classification based on the Revised International Staging System (R-ISS). Patients with Stage I disease have: ß2-M less than or equal to 3.5mg/L and albumin greater than or equal to 3.5 g/dL, Absence of higher-risk DNA [deletion(17p) and/or translocation t(4;14) and/or translocation t(14;16)], Normal blood levels of lactate dehydrogenase (LDH)
- Stage II diseaseMyeloma disease classification based on the Revised International Staging System (R-ISS). Patients with Stage II disease have: Neither Stage I nor Stage III disease
- Stage III diseaseMyeloma disease classification based on the Revised International Staging System (R-ISS) Patients with Stage III disease have: ß2-M greater than or equal to 5.5mg/L and either , Presence of higher-risk DNA abnormalities [deletion(17p) and/or translocation t(4;14) and/or translocation t(14;16)] or High blood levels of LDH
- Standard-dose chemotherapyAdministration of chemotherapy at a dose that does not completely destroy the bone marrow; also known asAdministration of chemotherapy at a dose that does not completely destroy the bone marrow; also known as conventional chemotherapy.conventional chemotherapy.
- Standard of careTreatment that experts agree is appropriate, accepted and widely used; also called standard therapy or best practice.
- Standard risk diseaseIndicates myeloma with an average prognosis.
- Standard therapyTreatment that has been shown to be safe and effective in clinical studies and is adopted as standard practice outside of clinical trials.
- Stem cellParent cell that grows and divides to produce red blood cells, white blood cells and platelets. Found primarily in the bone marrow, but also in the peripheral blood.
- Stem cell transplantTherapeutic procedure in which bone marrow or peripheral blood stem cells are collected, stored and infused into a patient following high-dose chemotherapy to restore blood cell production.
- Stevens-Johnson syndromeA rare, but very serious type of rash, resulting from an allergic reaction. It has been rarely documented in patients who received Revlimid. It requires immediate medical attention.
- StomatitisMouth sores.
- Stringent complete responseA treatment outcome where there are no detectable plasma cells in the bone marrow or myeloma proteins in the serum or urine using very sensitive techniques. A test known as free light chain ratio is also normal.
- Stromal cellStructural cells of the bone marrow that help support and nourish the blood-producing cells.
- Supplemental New Drug Application (sNDA)Compilation of information on the safety and efficacy of a marketed drug that is submitted to the FDA in order to request approval to market the drug for another indication.
- Supportive careTreatment that addresses the symptoms and complications of a disease rather than the disease itself. Examples in myeloma include bisphosphonates, growth factors (i.e., erythropoietin), antibiotics, orthopedic interventions and pain control measures.
- SynergisticActs in combination with another agent such that the activity is greater than the simple additive effect of the two agents.
- Syngeneic stem cell transplantProcedure in which bone marrow or peripheral blood stem cells from a patient’s identical twin are collected, stored and infused into the patient following high-dose chemotherapy or radiation therapy.
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- T cellType of lymphocyte (immune cell) that plays an important role in immune responses and targeted cell killing, also known as a T lymphocyte.
- T lymphocyteType of lymphocyte (immune cell) that plays an important role in immune responses and targeted cell killing, also known as a T lymphocyte.
- Tandem transplantType of transplantation technique where a patient receives two planned transplants within a short period of time. Patients may receive 2 autologous transplants or an autologous stem cell transplant followed by a mini-transplant two to four months afterward.
- TeratogenicRelating to or causing birth defects.
- Thalomid (thalidomide)Older oral drug with multiple anti-myeloma effects. Thalomid has been shown to be effective in newly diagnosed and relapsed or refractory myeloma alone and in combination with agents such as dexamethasone. It is chemically similar to Revlimid®.
- ThrombocytopeniaDecrease in the number of platelets (small cell fragments in the blood that help it to clot). A low level of platelets may increase the chance of bleeding.
- Time to progression (TTP)A measure of time after a disease is treated until the disease starts to get worse or progress.
- Tissue-type plasminogen activator (t-PA)Enzyme that helps dissolve blood clots and inhibits angiogenesis.
- Toxic epidermal necrosis (TEN)A rare but life-threatening skin reaction, where skin turns very red and peels off, similar to what you would see with a severe burn. It typically occurs as a side effect to certain drugs but may also appear as a result of infection or suppression of the immune system.
- Toxic epidermal necrosis (TEN)A rare but life-threatening skin reaction, where skin turns very red and peels off, similar to what you would see with a severe burn. It typically occurs as a side effect to certain drugs but may also appear as a result of infection or suppression of the immune system.
- TranslocationAn abnormal change in the DNA where two segments of different chromosomes switch positions.
- Treatment cyclesThe period in which treatment is given (e.g., 21 days or 28 days). It is usually followed by a rest period in between treatments.
- Tumor-induced hypercalcemia (TIH)Condition occurring in various forms of cancer noted by elevated levels of calcium in the blood due to increased bone destruction; also known as hypercalcemia of malignancy (HCM).
- Tumor lysis syndromeA condition that can occur during cancer treatment when large numbers of cancer cells die; the breaking up of the cells and release of the material into the blood can cause organ damage.
- Tumor microenvironmentThe normal cells, molecules and blood vessels that surround and feed a tumor cell. A tumor can change its microenvironment, and the microenvironment can affect how a tumor grows and spreads.
- Tumor necrosis factor-alpha (TNF-a)Cytokine with several effects in myeloma, including promotion of the growth of myeloma cells and activation of osteoclasts.
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- UrinalysisTest that determines the level of protein and various chemical compounds in the urine.
- Urine electrophoresis (UEP)Test used to detect and measure the levels of various proteins in the urine, especially Bence-Jones protein. Uses an electrical current to sort proteins by their size.
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- VADAn older type of chemotherapy treatment. It consists of the combination of two chemotherapy drugs (Vincristine, Adriamycin) plus dexamethasone, a steroid.
- Vascular endothelial growth factor (VEGF)One of the major growth factors that promotes the growth of new blood vessels (angiogenesis).
- Velcade® (also known as bortezomib)A highly effective myeloma drug, known as a proteasome inhibitor. It is usually given subcutaneously either alone or in combination with other myeloma drugs.
- VertebroplastyProcedure used to treat spinal compression fractures whereby cement is injected into the affected vertebrae to stabilize it.
- Very good partial response (VGPR)Treatment outcome where there is a greater than 90% decrease in M protein; also known as very good partial remission.
- VincristineA type of chemotherapy which is given intravenously (into a vein). It is part of an older type of myeloma treatment. See VAD.
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- White blood cell (WBC)One of the major cell types in the blood that is responsible for immune defenses; also called a leukocyte.
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- Zofran® (ondansetron)A type of medicine used to prevent or treat nausea and vomiting as a result of cancer treatment. It is given either orally or intravenously (into a vein).