A Phase I/II Trial of Ipilimumab After CD34-Selected Allogeneic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma
Overview
- Phase
- Phase 1
- Intervention
- Ipilimumab
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 3
- Locations
- 7
- Primary Endpoint
- Phase I: Maximum Tolerated Dose of Ipilimumab
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
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:
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)
Arms & Interventions
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.
Intervention: Ipilimumab
Outcomes
Primary Outcomes
Phase I: Maximum Tolerated Dose of Ipilimumab
Time Frame: 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)
Time Frame: 2 years
criteria of the International Myeloma Working Group