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

Overview

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.

SparkCures ID 1113
Trial Phase Phase 1/2
Enrollment 45 Patients
Treatments
  • Ipilimumab
Tags
Trial Sponsors
  • Memorial Sloan-Kettering Cancer Center
Trial Collaborators
  • Bristol-Myers Squibb
NCT Identifier

NCT04635735

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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)

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified Memorial Sloan Kettering Cancer Center

SparkCures Verified Accurate, up-to-date information. Learn more


Memorial Sloan Kettering Cancer Center

Basking Ridge, NJ

Memorial Sloan Kettering Cancer Center

Middletown, NJ

Memorial Sloan Kettering Bergen

Montvale, NJ

Memorial Sloan Kettering Cancer Center

Commack, NY

Memorial Sloan Kettering Cancer Center Nassau

Uniondale, NY

Memorial Sloan Kettering Cancer Center Westchester in West Harrison

West Harrison, NY

New Jersey
Memorial Sloan Kettering Cancer Center

Basking Ridge, NJ

Memorial Sloan Kettering Cancer Center

Middletown, NJ

Memorial Sloan Kettering Bergen

Montvale, NJ

New York
Verified Memorial Sloan Kettering Cancer Center

SparkCures Verified Accurate, up-to-date information. Learn more


Memorial Sloan Kettering Cancer Center

Commack, NY

Memorial Sloan Kettering Cancer Center Nassau

Uniondale, NY

Memorial Sloan Kettering Cancer Center Westchester in West Harrison

West Harrison, NY

Resources

There are no resources, links or videos to display for this clinical trial.

Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message