- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04635735
Study of Ipilimumab After Stem Cell Transplantation in People With Relapsed/Refractory Multiple Myeloma
A Phase I/II Trial of Ipilimumab After CD34-Selected Allogeneic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Gunjan Shah, MD
- Phone Number: 646-608-3734
- Email: ABMTTrials@mskcc.org
Study Contact Backup
- Name: Sergio Giralt, MD
- Phone Number: 646-608-3731
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth (Limited protocol activities)
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack (Limited protocol activities)
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 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 adjustment of Fludarabine for <70ml/min
- 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:.
- 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.
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Ipilimumab 3 mg/kg every 3 weeks for 4 doses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase I: Maximum Tolerated Dose of Ipilimumab
Time Frame: 1 year
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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.
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1 year
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Phase II: Progression Free Survival (PFS)
Time Frame: 2 years
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criteria of the International Myeloma Working Group
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2 years
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Collaborators and Investigators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Ipilimumab
Other Study ID Numbers
- 20-329
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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