study of ipilimumab after stem cell transplantation in people with relapsed/refractory multiple myeloma

Conditions: Relapsed/Refractory Multiple Myeloma

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.


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: 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 \ 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 exclusion criteria: exclusion criteria prior to allogeneic hematopoietic stem cell transplantation (allohsct): * patients ineligible for therapy with ipilimumab, for example:. 1. 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. 2. 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)

Keywords: ipilimumab stem cell transplantation 20-329