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

NCT04635735 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 20-329
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 7

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.

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

Ipilimumab; Stem Cell Transplantation; 20-329

Outcome Measures

Primary Outcomes (2)

• Phase I: Maximum Tolerated Dose of Ipilimumab

  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.

  1 year

• Phase II: Progression Free Survival (PFS)

  criteria of the International Myeloma Working Group

  2 years

Study Arms (1)

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.

Drug: Ipilimumab

Interventions

Ipilimumab DRUG

Ipilimumab 3 mg/kg every 3 weeks for 4 doses.

Ipilimumab After Stem Cell Transplantation

Eligibility Criteria

• Age: 21 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Gunjan Shah, MD
• Organization: Memorial Sloan Kettering Cancer Center

shahg@mskcc.org

646-608-3734

Study Officials

• Gunjan Shah, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: January 12, 2020
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: March 23, 2023
• Results First Posted: March 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (7)