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Active Not RecruitingNCT05675449

A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma

A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH CARFILZOMIB PLUS DEXAMETHASONE AND ELRANATAMAB IN COMBINATION WITH PF-07901801 IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
59 (estimated)
Sponsor
Pfizer · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose.

Conditions

Interventions

TypeNameDescription
DRUGElranatamabBCMA-CD3 bispecific antibody
DRUGCarfilzomibproteasome inhibitor
DRUGMaplirpaceptCD47-SIRP alpha-directed

Timeline

Start date
2022-12-14
Primary completion
2025-07-07
Completion
2028-02-29
First posted
2023-01-09
Last updated
2026-04-13

Locations

36 sites across 2 countries: United States, Israel

Regulatory

Source: ClinicalTrials.gov record NCT05675449. Inclusion in this directory is not an endorsement.

A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relap (NCT05675449) · Clinical Trials Directory