Study of Ipilimumab After Stem Cell Transplantation in People With Relapsed/Refractory Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
About this trial
This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma focused on measuring Ipilimumab, Stem Cell Transplantation, 20-329
Eligibility Criteria
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:
- Cardiac: LVEF at rest must be ≥ 50%
Hepatic:
- < 3x ULN ALT
- < 1.5 ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
- 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
- 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
Exclusion Criteria:
Exclusion Criteria prior to Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT):
Patients ineligible for therapy with ipilimumab, for example:.
- Active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone equivalents) or other immunosuppressive medications at enrollment. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome, Myasthenia Gravis).
- Female patients who are pregnant or breast-feeding.
- Patients with plasma cell leukemia at the time of diagnosis.
- Patients who have undergone prior allogeneic hematopoietic stem cell transplantation.
- Patients who have had a previous malignancy that is not in remission.
Exclusion Criteria prior to Ipilimumab:
- Active infection or treatment for infection (patients on Cytomegalovirus (CMV) therapy will be considered eligible; patients with CMV viremia by PCR or disease with end-organ involvement will not be eligible)
- Active GVHD of any grade or prior grade 3-4 GVHD
Active immune suppression, defined as:
- active use of calcineurin inhibitors, mycophenolate mofetil, or other immunomodulators
- steroid dosing exceeding 10 mg/d prednisone or equivalent
- Receiving immunomodulatory agents (ex. thalidomide, lenalidomide, pomalidomide)
Sites / Locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
- Memorial Sloan Kettering Commack (Limited Protocol Activities)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Arms of the Study
Arm 1
Experimental
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.