| ID | Type | Description | Link |
|---|---|---|---|
| 00-C-0201 |
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Background:
The mainstay of therapy for newly diagnosed multiple myeloma patients remains systemic chemotherapy. Although partial remissions of up to 60% are obtained with conventional regimens, multiple myeloma is essentially an incurable disease with a median survival of approximately 30 months.
Allogeneic stem cell transplantation (SCT) results in a high percentage of complete remissions, but it can be associated with significant treatment-related mortality, which has been primarily attributed to conventional myeloablative transplant regimens.
Recent clinical studies have shown that highly immunosuppressive yet non-myeloablative doses of fludarabine-based chemotherapy can result in alloengraftment. Even with a reduction in treatment related mortality, success with allogeneic SCT is limited by a significant risk of relapse.
Donor immunization with myeloma Id in the setting of a non-myeloablative allogeneic SCT may represent a novel strategy for the treatment of multiple myeloma.
Objectives:
Primary Objectives:
To induce cellular and humoral immunity in allogeneic stem cell donors and recipients against the unique idiotype expressed by the recipient's myeloma.
To determine whether antigen-specific immunity, induced in the stem cell donor, can be passively transferred to the allogeneic SCT recipient in the setting of a non-myeloablative conditioning regimen.
Secondary Objectives:
To evaluate the effect of the Fludarabine-(etoposide, doxorubicin, vincristine, prednisone, cyclophosphamide) EPOCH regimen on host T cell depletion and myeloid depletion prior to allogeneic SCT.
To determine the efficacy of a novel conventional chemotherapy regimen (Fludarabine-EPOCH) in the setting multiple myeloma.
To determine the treatment-related morbidity and mortality of allogeneic stem cell transplantation using a non-myeloablative conditioning regimen in multiple myeloma.
To determine if the re-vaccination of allogeneic stem cell donors with the unique idiotype expressed by the recipient's myeloma will enhance cellular and humoral immunity to patient specific-idiotype prior to lymphocyte donation for the treatment of patients with recurrent or progressive disease after transplantation.
Eligibility:
Patients 18-75 years of age with Immunoglobulin G (IgG) or Immunoglobulin A (IgA) multiple myeloma.
Patients must have achieved at least a partial remission following initial conventional chemotherapy regimen or after autologous stem cell transplantation.
Consenting first degree relative matched at 6/6 or 5/6 human leukocyte antigen (HLA) antigens.
Design:
Phase 2 trial using a non-myeloablative conditioning regimen to reduce treatment-related toxicity.
Recipient will undergo a plasmapheresis to obtain starting material for the isolation of idiotype
protein. Donors would be immunized with an Id vaccine prepared from the patient.
Prior to transplantation patients would receive a conventional chemotherapy regimen which contains agents active in myeloma and is T cell depleting. The allogeneic SCT would be performed with a conditioning regimen consisting of cyclophosphamide and fludarabine. The stem cell source would be blood mobilized with filgrastim. Recipients will be immunized with the Id vaccine following transplantation.
Background:
The mainstay of therapy for newly diagnosed multiple myeloma patients remains systemic chemotherapy. Although partial remissions of up to 60% are obtained with conventional regimens, multiple myeloma is essentially an incurable disease with a median survival of approximately 30 months.
Allogeneic stem cell transplantation (SCT) results in a high percentage of complete remissions, but it can be associated with significant treatment-related mortality, which has been primarily attributed to conventional myeloablative transplant regimens.
Recent clinical studies have shown that highly immunosuppressive yet non-myeloablative doses of fludarabine-based chemotherapy can result in allo-engraftment. Even with a reduction in treatment related mortality, success with allogeneic SCT is limited by a significant risk of relapse.
Donor immunization with myeloma Id in the setting of a non-myeloablative allogeneic SCT may represent a novel strategy for the treatment of multiple myeloma.
Objectives:
Primary Objectives:
To induce cellular and humoral immunity in allogeneic stem cell donors and recipients against the unique idiotype expressed by the recipient's myeloma.
To determine whether antigen-specific immunity, induced in the stem cell donor, can be passively transferred to the allogeneic SCT recipient in the setting of a non-myeloablative conditioning regimen.
Secondary Objectives:
To evaluate the effect of the Fludarabine-EPOCH regimen on host T cell depletion and myeloid depletion prior to allogeneic SCT.
To determine the efficacy of a novel conventional chemotherapy regimen (Fludarabine-EPOCH) in the setting multiple myeloma.
To determine the treatment-related morbidity and mortality of allogeneic stem cell transplantation using a non-myeloablative conditioning regimen in multiple myeloma.
To determine if the re-vaccination of allogeneic stem cell donors with the unique idiotype expressed by the recipient's myeloma will enhance cellular and humoral immunity to patient specific-idiotype prior to lymphocyte donation for the treatment of patients with recurrent or progressive disease after transplantation.
Eligibility:
Patients 18-75 years of age with IgG or IgA multiple myeloma.
Patients must have achieved at least a partial remission following initial conventional chemotherapy regimen or after autologous stem cell transplantation.
Consenting first degree relative matched at 6/6 or 5/6 HLA antigens.
Design:
Phase 2 trial using a non-myeloablative conditioning regimen to reduce treatment-related toxicity.
Recipient will undergo a plasmapheresis to obtain starting material for the isolation of idiotype protein. Donors would be immunized with an Id vaccine prepared from the patient.
Prior to transplantation patients would receive a conventional chemotherapy regimen which contains agents active in myeloma and is T cell depleting. The allogeneic SCT would be performed with a conditioning regimen consisting of cyclophosphamide and fludarabine. The stem cell source would be blood mobilized with filgrastim. Recipients will be immunized with the Id vaccine following transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recipient - Chemotherapy Group | Experimental | Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor (GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization. |
|
| Donor - Vaccine Generation Group | Other | 3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (Anti-idiotype-keyhole limpet hemocyanin) (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myeloma Immunoglobulin Idiotype Vaccine | Drug | 3 subcutaneous (SC) injections of myeloma protein within 10 weeks before stem cell collection the first (week 0), second (week 2), and third injection (week 6) with Id-KLH (0.5 mg SC day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Response | Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) > 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells. | 105 days |
| Number of Participants With Adverse Events | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. | 9 years |
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Patients with Immunoglobulin G (IgG) or Immunoglobulin A (IgA) multiple myeloma.
Patients have siblings.
Human leukocyte antigen (HLA) typing of recipient and donor(s) initiated.
Viral antibody screening initiated.
INCLUSION CRITERIA: Recipient:
Patients with IgG or IgA multiple myeloma.
Patients must have achieved at least a partial remission following initial conventional chemotherapy regimen or after autologous stem cell transplantation. Patients who have undergone tandem autologous stem transplants are eligible if they meet all other eligibility criteria. Patients who have achieved at least a partial remission to initial (primary) conventional chemotherapy will be encouraged to proceed to autologous transplantation, but will also be eligible for this protocol.
Patients 18-75 years of age. The upper age limit was chosen as it is felt that the toxicities would exceed potential benefit in this older population.
Karnofsky performance status greater than or equal to 80%.
Life expectancy greater than 6 months.
Left ventricular ejection fraction has to be greater than 50% by either multi-gated acquisition scan (MUGA) or 2-D echo.
Carbon monoxide diffusing capacity (DLCO) greater than 50% of the expected value when corrected for hemoglobin (Hb)(96).
Creatinine less than or equal to 1.5 mg/dl and a creatinine clearance greater than or equal to 50 ml/min.
Direct bilirubin less than or equal to 2.0 mg/dl serum glutamic oxaloacetic transaminase (SGOT) less than 4x top normal.
M-protein: the concentration in the harvested plasma must be greater than 70% of the total Ig of the corresponding isotype.
Patients must be human immunodeficiency virus (HIV)-negative. There is the theoretical possibility that the degree of immune suppression associated with the treatment may result in progression of HIV infection. Patients may be Hepatitis B core antigen positive, but surface antigen negative and without evidence of active infection. Patients must be Hepatitis C negative.
Not pregnant or lactating. Patients of childbearing potential must use an effective method of contraception. The effects of the chemotherapy, the subsequent transplant and the medications used after the transplant are highly likely to be harmful to a fetus. The effects upon breast milk are also unknown and may potentially be harmful to the infant.
Consenting first degree relative matched at 6/6 or 5/6 HLA antigens, this may include a mismatch at the D locus.
Ability to give informed consent.
INCLUSION CRITERIA: Donor:
Age 18-75 years. As the potential cerebrovascular and cardiac complications may potentially increase with age, age 75 has been chosen arbitrarily as the upper age limit. However, if it is determined after initial accrual of patients in this upper age range that this procedure is relatively safe, the age range may be extended.
No physical contraindications to stem cell donation (i.e. severe atherosclerosis, auto-immune disease, cerebrovascular accident, active malignancy (97). Patients with severe atherosclerosis by history will receive a cardiology consult and be judged eligible on a case by case basis.
Donors must be HIV-negative, hepatitis B surface antigen (HBsAg-), and Hepatitis C antibody negative. This is to prevent the possible transmission of these infections to the recipient.
Not pregnant or lactating. Donors of childbearing potential must use an effective method of contraception. The effects of cytokine administration on a fetus are unknown and may be potentially harmful. The effects upon breast milk are also unknown and may potentially be harmful to the infant.
Normal cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) numbers as defined by Clinical Center standards.
Ability to give informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Claude Sportes, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 47617 | Background | Stevenson GT, Stevenson FK. Antibody to a molecularly-defined antigen confined to a tumour cell surface. Nature. 1975 Apr 24;254(5502):714-6. doi: 10.1038/254714a0. No abstract available. | |
| 69552 | Background | Stevenson GT, Elliott EV, Stevenson FK. Idiotypic determinants on the surface immunoglobulin of neoplastic lymphocytes: a therapeutic target. Fed Proc. 1977 Aug;36(9):2268-71. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Recipient - Chemotherapy Group | Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor ( GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bortezomib | Drug | Induction chemotherapy: 1.3 mg/m^2 bolus intravenous injection twice weekly for 2 weeks (days 1, 4, 8, 11) followed by 10 day rest period (day 12-21) |
|
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| Cyclophosphamide | Drug | Induction chemotherapy: 600 mg/m^2 day 4 Transplant: 1200 mg/m^2 intravenous x 4 days (days -6, -5, -4, -3) |
|
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| Cyclosporine | Drug | Transplant: 2 mg/kg intravenous every 12 hours continuous intravenous or by mouth (PO) until day + 180 |
|
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| Doxorubicin hydrochloride | Drug | Induction chemotherapy: 10 mg/m^2 day continuous intravenous (CIV) days 1-3 |
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| Etoposide | Drug | Induction chemotherapy: 50 mg/m^2 day continuous intravenous days 1-3 |
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| Fludarabine phosphate | Drug | Induction chemotherapy: 25 mg/m^2 day intravenous days 1-3 Transplant: 30 mg/m^2 day x 4 days (days -6, -5, -4, -3 ) |
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| Prednisone | Drug | 60 mg/m^2 day 1-4 |
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| Vincristine Sulfate | Drug | Induction chemotherapy: 0.5 mg/m^2 day continuous intravenous days 1-3 |
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| Methotrexate | Drug | Transplant: 5 mg/m^2 intravenous on days +1, +3, +6, +11 |
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| GMCSF (granulocyte macrophage colony stimulating factor) | Biological | 250 mcg/m^2 subcutaneously every day, days 1-4 |
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| GCSF (granulocyte colony stimulating factor) | Biological | 10 mcg/kg per day subcutaneously daily from day 5 until absolute neutrophil count (ANC) > 1000/ul x 2 days |
|
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| 6173751 | Background | Miller RA, Maloney DG, Warnke R, Levy R. Treatment of B-cell lymphoma with monoclonal anti-idiotype antibody. N Engl J Med. 1982 Mar 4;306(9):517-22. doi: 10.1056/NEJM198203043060906. No abstract available. |
| 22773122 | Result | Foglietta M, Neelapu SS, Kwak LW, Jiang Y, Nattamai D, Lee ST, Fowler DH, Sportes C, Gress RE, Steinberg SM, Vence LM, Radvanyi L, Dwyer KC, Qazilbash MH, Bryant RN, Bishop MR. Neoantigen and tumor antigen-specific immunity transferred from immunized donors is detectable early after allogeneic transplantation in myeloma patients. Bone Marrow Transplant. 2013 Feb;48(2):269-77. doi: 10.1038/bmt.2012.132. Epub 2012 Jul 9. |
| 20661232 | Derived | Jamshed S, Fowler DH, Neelapu SS, Dean RM, Steinberg SM, Odom J, Bryant K, Hakim F, Bishop MR. EPOCH-F: a novel salvage regimen for multiple myeloma before reduced-intensity allogeneic hematopoietic SCT. Bone Marrow Transplant. 2011 May;46(5):676-81. doi: 10.1038/bmt.2010.173. Epub 2010 Jul 26. |
| FG001 |
| Donor - Vaccination Generation Group |
3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (Anti-idiotype-keyhole limpet hemocyanin) (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Recipient - Chemotherapy Group | Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization. |
| BG001 | Donor - Vaccination Generation Group | 3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Immune Response | Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) > 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells. | This outcome measure was only pre-specified to be measured in the recipient Arm/Group. | Posted | Number | Particpants | 105 days |
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| Primary | Number of Participants With Adverse Events | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. | Posted | Count of Participants | Participants | 9 years |
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9 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recipient - Chemotherapy Group | Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization. | 0 | 10 | 10 | 10 | 10 | 10 |
| EG001 | Donor - Vaccination Generation Group | 3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination | 0 | 10 | 0 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain or cramping | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea (without colostomy) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection) |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) for BMT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolic-Other (GGT) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mood alteration::Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea and vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Neurologic-Other (Neuropathy) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) for BMT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelets for BMT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| SGOT (AST) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| SGPT (ALT) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Transfusion: Platelets | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain or cramping | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
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| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
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| Allergy - Other (Transfusion reaction (platelets) | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
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| Amylase | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Bilirubin | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Bilirubin - graft versus host disease (GVHD) | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Cataract | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Catheter-related infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Chest pain (non-cardiac and non-pleuritic) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Constitutional Symptoms-Other (CGVHD-skin) | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Creatinine | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea (with colostomy) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea (without colostomy) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea (without colostomy) BMT | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness/lightheadedness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspareunia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemoglobin (hgb) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Ileus (or neuroconstipation) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutropenia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Infection w/out neutropenia, catheter related | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Infection without neutropenia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Infection without neutropenia, blood | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection without neutropenia, C-diff | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Infection without neutropenia, Nasal Pharynx | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection without neutropenia, wound | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection, Other (Upper respiratory infection (URI)) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection: blood | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Injection site reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Injection site reaction, bilat arms | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Injection site reaction, bilat legs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Joint, muscle, or bone (osseous)- Other (Calf cramping) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) for BMT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphatics | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphatics-Other (Adenopathy) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolic-Other (Hyperbilirubinemia; hyperbilirubinemia r/t GVH) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mood alteration-depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mood alteration-euphoria | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia (muscle ache) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuropathic pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | (e.g., jaw pain, neurologic pain, phantom limb pain, post infection-infectious neuralgia, or painful neuropathies |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) for BMT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Ocular-Other (Ocular cGVHD) | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - Other | General disorders | CTCAE (4.0) | Systematic Assessment | catheter site; hp and leg; hip and leg exacerbation related GCSF; meniscus tear |
|
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pigmentation changes (e.g., vitiligo) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelets for BMT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial effusion/pericarditis | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary-Other (URI) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash/desquamation for BMT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal bleeding/hematochezia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Salivary gland changes | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| SGOT (AST) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| SGPT (ALT) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Skin-Other (Drug reaction face, hands, neck) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Taste disturbance (dysgeusia) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombosis/embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Transfusion: Platelets for BMT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Transfusion: pRBCs | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Transfusion: pRBCs for BMT | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vasovagal episode | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia (joint pain) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematologic-Other (Splenomegaly in donor-resolved) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hot flashes/flushes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection) |
|
| Diarrhea for BMT | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr, Claude Sportes, M.D. | National Cancer Institute, National Institutes of Health | 301-435-5280 | csportes@mail.nih.gov |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D003520 | Cyclophosphamide |
| D016572 | Cyclosporine |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| C042382 | fludarabine phosphate |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D008727 | Methotrexate |
| D003115 | Colony-Stimulating Factors |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hispanic |
|
| Non Hispanic |
|
|