MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma

Purpose

The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.

Condition

  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy - Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody - Measurable disease defined by at least one of the following: 1. Serum M-protein >/= 0.5 g/dL by SPEP 2. Urinary M-protein excretion >/= 200 mg/24 hours by UPEP 3. Serum immunoglobulin FLC >/= 10 mg/dL (>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio - ECOG performance status 0 -1 - Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade </= 1

Exclusion Criteria

  • Active plasma cell leukemia - Amyloidosis - Stem cell transplant with 12 weeks prior to enrollment, or active GVHD - POEMS syndrome - Any active uncontrolled bacterial, fungal, or viral infection - Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment - Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer) - Sub-Study A Only: Previous treatment with BCMA bispecific antibody - Sub-Study B Only: Previous treatment with BCMA directed therapy

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sub-Study A 		BCMA-CD3 bispecific antibody + gamma secretase inhibitor
  • Drug: Elranatamab + Nirogacestat
    BCMA-CD3 bispecific antibody + gamma secretase inhibitor
    Other names:
    • PF-06863135, Ogsiveo
Experimental
Sub-Study B 		BCMA-CD3 bispecific antibody + immunomodulatory drug
  • Drug: Elranatamab + lenalidomide + dexamethasone
    BCMA-CD3 bispecific antibody + immunomodulatory
    Other names:
    • PF-06863135; Revlimid

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com