Study of Ipilimumab After Stem Cell Transplantation in People With Relapsed/Refractory Multiple Myeloma
- Registration Number
- NCT04635735
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
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)
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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
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Eligible for CD34-selected HSCT according to MSKCC adult BMT guidelines.
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Have a 10/10 matched donor
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Age ≥ 21, < 73 years.
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Karnofsky (adult) Performance Status ≥ 70%.
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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.
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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
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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 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.
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Patients with plasma cell leukemia at the time of diagnosis.
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Patients who have undergone prior allogeneic hematopoietic stem cell transplantation.
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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)
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Active GVHD of any grade or prior grade 3-4 GVHD
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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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ipilimumab After Stem Cell Transplantation Ipilimumab 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Commack (Limited Protocol Activities)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
🇺🇸Uniondale, New York, United States