NCT04635735 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2023-03-23

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Phase I: Maximum Tolerated Dose of Ipilimumab

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outcome · POSTED

Phase II: Progression Free Survival (PFS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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)
healthy Volunteers: false
maximum Age: 73 Years
minimum Age: 21 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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 Names
Drug: Ipilimumab
label
Ipilimumab After Stem Cell Transplantation
type
EXPERIMENTAL

interventions

arm Group Labels
Ipilimumab After Stem Cell Transplantation
description
Ipilimumab 3 mg/kg every 3 weeks for 4 doses.
name
Ipilimumab
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

intervention Model Description

This is a phase I/II, single arm, open label trial.

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 3
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Phase I: Maximum Tolerated Dose of Ipilimumab
time Frame
1 year
description
criteria of the International Myeloma Working Group
measure
Phase II: Progression Free Survival (PFS)
time Frame
2 years

Full study description

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.

Source references