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

Pfizer

Status and phase: Enrolling; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Elranatamab + lenalidomide + dexamethasone; Drug: Elranatamab + Nirogacestat

Study type: Interventional

Funder types: Industry

Identifiers

NCT05090566

C1071004

Umbrella Study (Other Identifier)

MAGNETISMM-4 (Other Identifier)

2021-003885-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Sub-Study A

Experimental group

Description:

BCMA-CD3 bispecific antibody + gamma secretase inhibitor

Treatment:

Drug: Elranatamab + Nirogacestat

Sub-Study B

Experimental group

Description:

BCMA-CD3 bispecific antibody + immunomodulatory drug

Treatment:

Drug: Elranatamab + lenalidomide + dexamethasone