Relapsed/Refractory Multiple Myeloma
Conditions
Keywords
Ipilimumab, Stem Cell Transplantation, 20-329
Brief summary
This study will test the safety of ipilimumab to see what effects, if any, the drug has when used as maintenance therapy for people with relapsed/refractory multiple myeloma who have received chemotherapy and allogeneic hematopoietic stem cell transplant (AHCT). The investigators also want to find out whether giving ipilimumab after chemotherapy and AHCT is a better way to control the multiple myeloma than chemotherapy and AHCT alone.
Interventions
DRUGIpilimumab
Ipilimumab 3 mg/kg every 3 weeks for 4 doses.
Sponsors
Bristol-Myers Squibb
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a phase I/II, single arm, open label trial.
Eligibility
Sex/Gender
ALL
Age
21 Years to 73 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria prior to Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT): * Willing and able to participate as a research subject and provide informed consent (Note: an LAR may sign the consent form on the partipant's behalf) * Diagnosis of relapsed refractory multiple myeloma defined as more than 2 lines of prior therapy with at least a very good partial remission to most recent salvage therapy. * Patients should have R-ISS stage II or III disease at diagnosis or high risk cytogenetics by IMWG criteria (t(4;14), del(17/17p), t(14;16), t(14;20), nonhyperdiploidy, and gain(1q)) at any time since diagnosis Note:. A line of therapy is treatment between diagnosis and progression or between two progressions * Eligible for CD34-selected HSCT according to MSKCC adult BMT guidelines. * Have a 10/10 matched donor * Age ≥ 21, \< 73 years. * Karnofsky (adult) Performance Status ≥ 70%. * Patients must have adequate organ function measured by: 1. Cardiac: LVEF at rest must be ≥ 50% 2. Hepatic: * \< 3x ULN ALT * \< 1.5 ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia. 3. Renal: serum creatinine \<1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 40 ml/min (measured or calculated/estimated) with dose adjustment of Fludarabine for \<70ml/min 4. Pulmonary: DLCO \> 50% of predicted (corrected for hemoglobin). Inclusion Criteria prior to Ipilimumab: * Non progressive myeloma (partial response or better) as defined by International Myeloma Working Group (IMWG) criteria * Engraftment of all cell lines without transfusion dependence, defined as: * absolute neutrophil count \> 1.0K/mcL x 3 consecutive days * platelets \> 50K/mcLx 7 consecutive days without platelet transfusion * no platelet or RBC transfusions within the preceding 7 days * ≥ 80% donor chimerism in the bone marrow
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Maximum Tolerated Dose of Ipilimumab | 1 year | A maximum of 12 patients will be accrued and DLTs will be assessed in these patients. If any DLT is observed in more than one of the six patient cohort, a lower dose of ipilimumab will be evaluated in a new six patient cohort. |
| Phase II: Progression Free Survival (PFS) | 2 years | criteria of the International Myeloma Working Group |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ipilimumab After Stem Cell Transplantation The patient will be admitted to a single room on the Adult Transplantation Service and allogeneic CD34-selected PBSC or marrow transplantation performed as per MSKCC adult BMT guidelines. Patients will be evaluated at approximately day 100 (±2 weeks) after allo-HSCT.
Ipilimumab: Ipilimumab 3 mg/kg every 3 weeks for 4 doses. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Ipilimumab After Stem Cell Transplantation |
|---|---|
| Age, Continuous | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Phase II: Progression Free Survival (PFS)
criteria of the International Myeloma Working Group
Time frame: 2 years
Population: Data were not collected
Primary
Phase I: Maximum Tolerated Dose of Ipilimumab
A maximum of 12 patients will be accrued and DLTs will be assessed in these patients. If any DLT is observed in more than one of the six patient cohort, a lower dose of ipilimumab will be evaluated in a new six patient cohort.
Time frame: 1 year
Population: Data were not collected