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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07892 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Poor accrual
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This phase II trial studies how well a reduced intensity conditioning regimen after donor stem cell transplant works in treating patients with multiple myeloma that has come back (relapsed). Drugs used in chemotherapy, such as cyclophosphamide, tacrolimus, and mycophenolate mofetil, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving a reduce intensity conditioning regimen consisting of cyclophosphamide, tacrolimus, mycophenolate mofetil, and daratumumab after donor stem cell transplant may improve survival and reduce the risk of multiple myeloma coming back.
PRIMARY OBJECTIVE:
I. To determine the 2-year progression-free survival (PFS) for haploidentical, matched or mismatched, related or unrelated reduce intensity allogenic hematopoietic stem cell transplantation (allo HSCT) in relapsed multiple myeloma (MM) patients.
SECONDARY OBJECTIVES:
I. To determine 2 year overall survival (OS). II. To determine the cumulative incidence of grade II-IV acute-graft-versushost-disease (aGVHD) at day 100 and 180.
III. To determine the 100 days, 1 year and 2 year cumulative incidence of treatment-related mortality (TRM).
IV. To assess one-year GVHD-free relapse-free survival (GRFS). V. To determine the cumulative incidence of chronic graft-versus-hostdisease (cGVHD) Va. To assess overall and best response rates 100 days after allo HCT, 3 months, 6 months and every 6 months thereafter until end of daratumumab maintenance.
VI. To determine rate of relapse after allo HSCT followed by maintenance. VII. To determine rate of minimal residual disease (MRD) negativity using next generation sequencing (Food and Drug Administration [FDA] approved) in patients achieving a very good partial response (VGPR) or better.
CORRELATIVE OBJECTIVE:
I. To determine immune reconstitution pattern on days +30, +100, +180 and +365 following allo HSCT.
OUTLINE:
Patients receive fludarabine intravenously (IV) on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus orally (PO) or twice daily (BID) or IV starting on day 5, and mycophenolate mofetil IV or PO three times daily (TID) on days 5 to 35. Patients also receive daratumumab IV starting between day 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 2 years post stem cell transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (conditioning regimen, stem cell transplant) | Experimental | Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | Undergo allogeneic hematopoietic stem cell transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year Progression-free Survival (PFS) | Patients who do not relapse or die will be censored at the date of last clinical assessment. Kaplan-Meier curves will be generated to estimate the PFS rates at 2 years posttransplant. To evaluate the potential association between patient characteristics and PFS, the log-rank test will be used to compare the PFS curves and Cox proportional hazard regression model will be used to estimate the hazard ratio. | From the date of transplant until the date of relapse or date of death from any cause, assessed at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Adverse events by grade will be summarized. The occurrence of grade 3+ adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) will be summarized as well. Adverse events will initially be reviewed regardless of attribution, but also according to whether adverse events are possibly, probably, or definitely related to treatment. | Up to 2 years post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Minimal Residual Disease-negativity | Will be defined as the proportion of patients who achieved minimal residual disease-negative status at the respective time point, in accordance with the International Myeloma Working Group criteria. Minimal residual disease was evaluated by next-generation sequencing using ClonoSEQ Assay. | Baseline up to 365 days post-transplant |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srinivas Devarakonda, M.D. | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Conditioning Regimen, Stem Cell Transplant) | Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplantation Cyclophosphamide: Given IV Daratumumab: Given IV Fludarabine: Given IV Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given PO or IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2021 |
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|
| Cyclophosphamide | Drug | Given IV |
|
|
| Daratumumab | Biological | Given IV |
|
|
| Fludarabine | Drug | Given IV |
|
|
| Melphalan | Drug | Given IV |
|
|
| Mycophenolate Mofetil | Drug | Given IV or PO |
|
|
| Tacrolimus | Drug | Given PO or IV |
|
|
| Number of Patients With Grade II-IV Acute Graft-versus Host Disease (GvHD (aGVHD) | The event will be onset of grade II-IV aGvHD and time to aGvHD will be defined as the period of time from transplantation to the event of aGvHD. Death and early relapse without aGvHD will be competing risks. Cumulative incidence rate of aGVHD with 95% confidence intervals will be estimated from the cumulative incidence curves. To evaluate the association between patient characteristics and aGVHD, the Gray's test accounting for competing risks will be used to compare the cumulative incidence curves and a proportional hazards model for the sub distribution of competing risks will be used to estimate the hazard ratio. The cumulative incidence of chronic GVHD (cGVHD) will be similarly analyzed. | Up to 6 weeks |
| Rate of Relapse | Patients without relapse or death will be censored at last clinical assessment date. The similar analysis approach used for outcome of aGVHD will be applied. | From the date of transplant to relapse treating death from any cause as a competing risk, assessed up to 2 years |
| Overall Survival (OS) | A similar analysis approach described above for PFS will be applied for the OS analysis. | From the date of transplant to death or last contact date if no death, assessed up to 2 years |
| 1- Year GVHD-free Relapse-free Survival (GRFS) | Patients who do not experience an event will be censored at the date of last clinical assessment. A similar analysis approach described above for PFS will be applied for the GRFS analysis. | From the date of transplant until the date of grade II-IV acute GVHD, chronic GVHD, disease relapse or progression, or death from any cause, whichever occurs first, assessed at 1 year |
| 100-day Cumulative Incidence of Treatment-related Mortality (TRM) | The event will be death due to reasons other than disease. The competing risk for non relapsed mortality (NRM) will be death due to disease. The cumulative incidence curve accounting competing risks will be generated to estimate the cumulative incidence rate at various time points. | From the date of transplant to date of death, assessed up to 100 days |
| 1-year Cumulative Incidence TRM | The event will be death due to reasons other than disease. The competing risk for NRM will be death due to disease. The cumulative incidence curve accounting competing risks will be generated to estimate the cumulative incidence rate at various time points. | From the date of transplant to date of death, assessed at 1 year |
| 2-year Cumulative Incidence of TRM | The event will be death due to reasons other than disease. The competing risk for NRM will be death due to disease. The cumulative incidence curve accounting competing risks will be generated to estimate the cumulative incidence rate at various time points. | From the date of transplant to date of death, assessed at 2 years |
| Overall Response Rate | The proportion of each type of response with a 95% confidence interval (CI) will be reported for all evaluable patients, assuming a binomial distribution. | Up to 2 years post-transplant |
| Number of Patients With a Partial Response | The proportion of each type of response with a 95% CI will be reported for all evaluable patients, assuming a binomial distribution. | Approximately 11 months |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Conditioning Regimen, Stem Cell Transplant) | Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplantation Cyclophosphamide: Given IV Daratumumab: Given IV Fludarabine: Given IV Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given PO or IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | 2-year Progression-free Survival (PFS) | Patients who do not relapse or die will be censored at the date of last clinical assessment. Kaplan-Meier curves will be generated to estimate the PFS rates at 2 years posttransplant. To evaluate the potential association between patient characteristics and PFS, the log-rank test will be used to compare the PFS curves and Cox proportional hazard regression model will be used to estimate the hazard ratio. | Due to low patient accrual to study unable to collect and analyze data | Posted | From the date of transplant until the date of relapse or date of death from any cause, assessed at 2 years |
|
| |||||||||||||||||||
| Secondary | Incidence of Adverse Events | Adverse events by grade will be summarized. The occurrence of grade 3+ adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) will be summarized as well. Adverse events will initially be reviewed regardless of attribution, but also according to whether adverse events are possibly, probably, or definitely related to treatment. | Data was unable to be collected and analyzed due to low patient accrual to study | Posted | Up to 2 years post-transplant |
|
| |||||||||||||||||||
| Secondary | Number of Patients With Grade II-IV Acute Graft-versus Host Disease (GvHD (aGVHD) | The event will be onset of grade II-IV aGvHD and time to aGvHD will be defined as the period of time from transplantation to the event of aGvHD. Death and early relapse without aGvHD will be competing risks. Cumulative incidence rate of aGVHD with 95% confidence intervals will be estimated from the cumulative incidence curves. To evaluate the association between patient characteristics and aGVHD, the Gray's test accounting for competing risks will be used to compare the cumulative incidence curves and a proportional hazards model for the sub distribution of competing risks will be used to estimate the hazard ratio. The cumulative incidence of chronic GVHD (cGVHD) will be similarly analyzed. | Posted | Number | participants | Up to 6 weeks |
| |||||||||||||||||||
| Secondary | Rate of Relapse | Patients without relapse or death will be censored at last clinical assessment date. The similar analysis approach used for outcome of aGVHD will be applied. | Due to low patient accrual to study unable to collect and analyze data | Posted | From the date of transplant to relapse treating death from any cause as a competing risk, assessed up to 2 years |
|
| |||||||||||||||||||
| Secondary | Overall Survival (OS) | A similar analysis approach described above for PFS will be applied for the OS analysis. | Due to low patient accrual to study unable to collect and analyze data | Posted | From the date of transplant to death or last contact date if no death, assessed up to 2 years |
|
| |||||||||||||||||||
| Secondary | 1- Year GVHD-free Relapse-free Survival (GRFS) | Patients who do not experience an event will be censored at the date of last clinical assessment. A similar analysis approach described above for PFS will be applied for the GRFS analysis. | Due to low patient accrual to study unable to collect and analyze data | Posted | From the date of transplant until the date of grade II-IV acute GVHD, chronic GVHD, disease relapse or progression, or death from any cause, whichever occurs first, assessed at 1 year |
|
| |||||||||||||||||||
| Secondary | 100-day Cumulative Incidence of Treatment-related Mortality (TRM) | The event will be death due to reasons other than disease. The competing risk for non relapsed mortality (NRM) will be death due to disease. The cumulative incidence curve accounting competing risks will be generated to estimate the cumulative incidence rate at various time points. | Due to low patient accrual to study unable to collect and analyze data | Posted | From the date of transplant to date of death, assessed up to 100 days |
|
| |||||||||||||||||||
| Secondary | 1-year Cumulative Incidence TRM | The event will be death due to reasons other than disease. The competing risk for NRM will be death due to disease. The cumulative incidence curve accounting competing risks will be generated to estimate the cumulative incidence rate at various time points. | Due to low patient accrual to study unable to collect and analyze data | Posted | From the date of transplant to date of death, assessed at 1 year |
|
| |||||||||||||||||||
| Secondary | 2-year Cumulative Incidence of TRM | The event will be death due to reasons other than disease. The competing risk for NRM will be death due to disease. The cumulative incidence curve accounting competing risks will be generated to estimate the cumulative incidence rate at various time points. | Due to low patient accrual to study unable to collect and analyze data | Posted | From the date of transplant to date of death, assessed at 2 years |
|
| |||||||||||||||||||
| Secondary | Overall Response Rate | The proportion of each type of response with a 95% confidence interval (CI) will be reported for all evaluable patients, assuming a binomial distribution. | Due to low patient accrual to study unable to collect and analyze data | Posted | Up to 2 years post-transplant |
|
| |||||||||||||||||||
| Secondary | Number of Patients With a Partial Response | The proportion of each type of response with a 95% CI will be reported for all evaluable patients, assuming a binomial distribution. | Posted | Number | patients | Approximately 11 months |
|
| ||||||||||||||||||
| Other Pre-specified | Rate of Minimal Residual Disease-negativity | Will be defined as the proportion of patients who achieved minimal residual disease-negative status at the respective time point, in accordance with the International Myeloma Working Group criteria. Minimal residual disease was evaluated by next-generation sequencing using ClonoSEQ Assay. | Due to low patient accrual to study unable to collect and analyze data | Posted | Baseline up to 365 days post-transplant |
|
|
Adverse event information was collected for patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion up to 1 year.
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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 | Treatment (Conditioning Regimen, Stem Cell Transplant) | Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplantation Cyclophosphamide: Given IV Daratumumab: Given IV Fludarabine: Given IV Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given PO or IV | 1 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Metabolism and Nutrition Disorders | Metabolism and nutrition disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE version 5.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE version 5.0 | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE version 5.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE version 5.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | CTCAE version 5.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Bronchial stricture | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE version 5.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | CTCAE version 5.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Epstein-Barr virus infection reactivation | Infections and infestations | CTCAE version 5.0 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | CTCAE version 5.0 | Systematic Assessment |
| |
| Generalized edema | General disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE version 5.0 | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCAE version 5.0 | Systematic Assessment |
|
The trial was terminated early due to poor patient accrual
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Srinivas Devarakonda | The Ohio State University Comprehensive Cancer Center | 614-293-3196 | Srinivas.Devarakonda@osumc.edu |
| Oct 25, 2022 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2021 | Oct 25, 2022 | ICF_003.pdf |
Not provided
| 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 |
|---|---|
| D033581 | Stem Cell Transplantation |
| D003520 | Cyclophosphamide |
| C556306 | daratumumab |
| C024352 | fludarabine |
| D008558 | Melphalan |
| D009173 | Mycophenolic Acid |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|