Description:
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.
Title
- Brief Title: Study of Ipilimumab After Stem Cell Transplantation in People With Relapsed/Refractory Multiple Myeloma
- Official Title: A Phase I/II Trial of Ipilimumab After CD34-Selected Allogeneic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID:
20-329
- NCT ID:
NCT04635735
Conditions
- Relapsed/Refractory Multiple Myeloma
Interventions
Drug | Synonyms | Arms |
---|
Ipilimumab | | Ipilimumab After Stem Cell Transplantation |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Ipilimumab After Stem Cell Transplantation | Experimental | 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. | |
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 <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
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)
Maximum Eligible Age: | 73 Years |
Minimum Eligible Age: | 21 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Phase I: maximum tolerated dose of Ipilimumab |
Time Frame: | 1 year |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
Trial Keywords
- Ipilimumab
- Stem Cell Transplantation
- 20-329
Last Updated
January 29, 2021