Trial Outcomes & Findings for Study of Ipilimumab After Stem Cell Transplantation in People With Relapsed/Refractory Multiple Myeloma (NCT NCT04635735)

NCT ID: NCT04635735

Last Updated: 2023-03-23

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2023-03-23

Participant Flow

Participant milestones

Measure	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. Ipilimumab: Ipilimumab 3 mg/kg every 3 weeks for 4 doses.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Ipilimumab After Stem Cell Transplantation n=3 Participants 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. Ipilimumab: Ipilimumab 3 mg/kg every 3 weeks for 4 doses.
Age, Continuous	62 years n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	3 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Data were not collected

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 years

Population: Data were not collected

criteria of the International Myeloma Working Group

Outcome measures

Outcome data not reported

Adverse Events

Ipilimumab After Stem Cell Transplantation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gunjan Shah, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-608-3734

Email: shahg@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place