A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

Sponsor
Genentech, Inc.
Study ID
NCT05927571
Phase
PHASE1
Status
Recruiting
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Conditions

  • Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cevostamab — DRUG
    Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.
  • Elranatamab — DRUG
    Elranatamab solution for injection will be administered SC as specified in each treatment arm.
  • Tocilizumab — DRUG
    Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

Study Details

The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.

Key Dates

Start date
Aug 10, 2023
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-In Cohort
    Participants will receive cevostamab, intravenously (IV), in combination with elranatamab, subcutaneously (SC), with step-up dosing of each drug in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.
  • Experimental: Dose Expansion Cohort (Combined Therapy)
    Participants will receive cevostamab, IV, in combination with elranatamab, SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.
  • Experimental: Dose Expansion Cohort (Monotherapy)
    Participants will receive elranatamab SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: From signing of informed consent up to end of study (EOS) (approximately 36 months) ]

Central Contacts

  • GO43979 https://forpatients.roche.com/
    888-662-6728 (U.S. Only)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

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