Trial Outcomes & Findings for Reduce Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed Multiple Myeloma (NCT NCT04205240)

NCT ID: NCT04205240

Last Updated: 2023-09-28

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

From the date of transplant until the date of relapse or date of death from any cause, assessed at 2 years

Results posted on

2023-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reduce Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Conditioning Regimen, Stem Cell Transplant) n=1 Participants 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
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

PRIMARY outcome

Timeframe: From the date of transplant until the date of relapse or date of death from any cause, assessed at 2 years

Population: Due to low patient accrual to study unable to collect and analyze data

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years post-transplant

Population: Data was unable to be collected and analyzed due to low patient accrual to study

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 weeks

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.

Outcome measures

Outcome measures
Measure	Treatment (Conditioning Regimen, Stem Cell Transplant) n=1 Participants 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
Number of Patients With Grade II-IV Acute Graft-versus Host Disease (GvHD (aGVHD)	0 participants

SECONDARY outcome

Timeframe: From the date of transplant to date of death, assessed at 2 years

Population: Due to low patient accrual to study unable to collect and analyze data

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years post-transplant

Population: Due to low patient accrual to study unable to collect and analyze data

The proportion of each type of response with a 95% confidence interval (CI) will be reported for all evaluable patients, assuming a binomial distribution.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 11 months

The proportion of each type of response with a 95% CI will be reported for all evaluable patients, assuming a binomial distribution.

Outcome measures

Outcome measures
Measure	Treatment (Conditioning Regimen, Stem Cell Transplant) n=1 Participants 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
Number of Patients With a Partial Response	1 patients

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 365 days post-transplant

Population: Due to low patient accrual to study unable to collect and analyze data

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.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Conditioning Regimen, Stem Cell Transplant)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Conditioning Regimen, Stem Cell Transplant) n=1 participants at risk 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
Cardiac disorders Cardiac arrest	100.0% 1/1 • Number of events 1 • 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.
Metabolism and nutrition disorders Metabolism and Nutrition Disorders	100.0% 1/1 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	100.0% 1/1 • Number of events 3 • 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.

Other adverse events

Other adverse events
Measure	Treatment (Conditioning Regimen, Stem Cell Transplant) n=1 participants at risk 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
Gastrointestinal disorders Abdominal Distension	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders Abdominal Pain	100.0% 1/1 • Number of events 1 • 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.
Metabolism and nutrition disorders Acidosis	100.0% 1/1 • Number of events 1 • 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.
Investigations Activated partial thromboplastin time prolonged	100.0% 1/1 • Number of events 1 • 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.
Renal and urinary disorders Acute kidney injury	100.0% 1/1 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	100.0% 1/1 • Number of events 1 • 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.
Psychiatric disorders Agitation	100.0% 1/1 • Number of events 1 • 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.
Investigations Alkaline phosphatase increased	100.0% 1/1 • Number of events 1 • 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.
Metabolism and nutrition disorders Alkalosis	100.0% 1/1 • Number of events 1 • 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.
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 1 • 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.
Metabolism and nutrition disorders Anorexia	100.0% 1/1 • Number of events 1 • 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.
Psychiatric disorders Anxiety	100.0% 1/1 • Number of events 1 • 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.
Investigations Aspartate aminotransferase increased	100.0% 1/1 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Aspiration	100.0% 1/1 • Number of events 1 • 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.
Nervous system disorders Ataxia	100.0% 1/1 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Atelectasis	100.0% 1/1 • Number of events 1 • 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.
Investigations Blood bilirubin increased	100.0% 1/1 • Number of events 1 • 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.
Investigations Blood lactate dehydrogenase increased	100.0% 1/1 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Bone pain	100.0% 1/1 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	100.0% 1/1 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Bronchial stricture	100.0% 1/1 • Number of events 1 • 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.
General disorders Chills	100.0% 1/1 • Number of events 1 • 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.
Renal and urinary disorders Chronic Kidney Disease	100.0% 1/1 • Number of events 1 • 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.
Nervous system disorders Cognitive disturbance	100.0% 1/1 • Number of events 1 • 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.
Psychiatric disorders Confusion	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders Constipation	100.0% 1/1 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • Number of events 1 • 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.
Investigations Creatinine increased	100.0% 1/1 • Number of events 1 • 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.
Immune system disorders Cytokine release syndrome	100.0% 1/1 • Number of events 1 • 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.
Metabolism and nutrition disorders Dehydration	100.0% 1/1 • Number of events 1 • 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.
Psychiatric disorders Delirium	100.0% 1/1 • Number of events 1 • 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.
Psychiatric disorders Depression	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders Dry mouth	100.0% 1/1 • Number of events 1 • 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.
Nervous system disorders Dysarthria	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders Dyspepsia	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders Dysphagia	100.0% 1/1 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • Number of events 1 • 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.
General disorders Edema face	100.0% 1/1 • Number of events 1 • 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.
General disorders Edema limbs	100.0% 1/1 • Number of events 1 • 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.
Investigations Ejection fraction decreased	100.0% 1/1 • Number of events 1 • 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.
Nervous system disorders Encephalopathy	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders Enterocolitis	100.0% 1/1 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	100.0% 1/1 • Number of events 1 • 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.
Infections and infestations Epstein-Barr virus infection reactivation	100.0% 1/1 • Number of events 1 • 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.
Gastrointestinal disorders Esophagitis	100.0% 1/1 • Number of events 1 • 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.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • 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.
General disorders Fever	100.0% 1/1 • Number of events 1 • 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.
Investigations Forced expiratory volume decreased	100.0% 1/1 • Number of events 1 • 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.
General disorders Generalized edema	100.0% 1/1 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	100.0% 1/1 • Number of events 1 • 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.
Psychiatric disorders Hallucinations	100.0% 1/1 • Number of events 1 • 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.
Nervous system disorders Headache	100.0% 1/1 • Number of events 1 • 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.
Renal and urinary disorders Hematuria	100.0% 1/1 • Number of events 1 • 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.
Blood and lymphatic system disorders Hemolysis	100.0% 1/1 • Number of events 1 • 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.

Additional Information

Dr. Srinivas Devarakonda

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-3196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place