Study of Ipilimumab After Stem Cell Transplantation in People With Relapsed/Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Nov 24, 2023
  • participants needed
    45
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 24 March 2022

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.

Details
Condition Relapsed/Refractory Multiple Myeloma
Treatment Ipilimumab
Clinical Study IdentifierNCT04635735
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
Inclusion Criteria prior to Ipilimumab
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
Engraftment of all cell lines without transfusion dependence, defined as
adjustment of Fludarabine for <70ml/min
absolute neutrophil count > 1.0K/mcL x 3 consecutive days
platelets > 50K/mcLx 7 consecutive days without platelet transfusion
Pulmonary: DLCO > 50% of predicted (corrected for hemoglobin)
no platelet or RBC transfusions within the preceding 7 days
Non progressive myeloma (partial response or better) as defined by International
Myeloma Working Group (IMWG) criteria
≥ 80% donor chimerism in the bone marrow

Exclusion Criteria

Patients ineligible for therapy with ipilimumab, for example
Female patients who are pregnant or breast-feeding
Exclusion Criteria prior to Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
Patients with plasma cell leukemia at the time of diagnosis
Patients who have undergone prior allogeneic hematopoietic stem cell transplantation
Active autoimmune disease or any condition requiring systemic treatment with
Patients who have had a previous malignancy that is not in remission
either corticosteroids (>10 mg daily of prednisone equivalents) or other
Exclusion Criteria prior to Ipilimumab
immunosuppressive medications at enrollment. Inhaled or topical steroids and
Active GVHD of any grade or prior grade 3-4 GVHD
adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in
Active immune suppression, defined as
the absence of active autoimmune disease
History of motor neuropathy considered to be of autoimmune origin (e.g
steroid dosing exceeding 10 mg/d prednisone or equivalent
Guillain-Barre Syndrome, Myasthenia Gravis)
Receiving immunomodulatory agents (ex. thalidomide, lenalidomide, pomalidomide)
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 use of calcineurin inhibitors, mycophenolate mofetil, or other
immunomodulators
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