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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04635735
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma Drug: Ipilimumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a phase I/II, single arm, open label trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Ipilimumab After CD34-Selected Allogeneic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Ipilimumab

Arm Intervention/treatment
Experimental: Ipilimumab After Stem Cell Transplantation
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.
Drug: Ipilimumab
Ipilimumab 3 mg/kg every 3 weeks for 4 doses.




Primary Outcome Measures :
  1. Phase I: maximum tolerated dose of Ipilimumab [ Time Frame: 1 year ]
    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.

  2. Phase II: progression free survival (PFS) [ Time Frame: 2 years ]
    criteria of the International Myeloma Working Group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04635735


Contacts
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Contact: Gunjan Shah, MD 646-608-3734 shahg@mskcc.org
Contact: Sergio Giralt, MD 646-608-3731

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Gunjan Shah, MD    646-608-3734      
Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Gunjan Shah, MD    646-608-3734      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Gunjan Shah, MD    646-608-3734      
United States, New York
Memorial Sloan Kettering Commack (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Gunjan Shah, MD    646-608-3734      
Memorial Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Gunjan Shah, MD    646-608-3734      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Gunjan Shah, MD    646-608-3734      
Principal Investigator: Gunjan Shah, MD         
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Gunjan Shah, MD    646-608-3734      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Bristol-Myers Squibb
Investigators
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Principal Investigator: Gunjan Shah, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04635735    
Other Study ID Numbers: 20-329
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Ipilimumab
Stem Cell Transplantation
20-329
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents