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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)

ConditionRelapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Diagnosis of R/R MM per IMWG criteria

For female participants of childbearing potential: agreement to remain abstinent or use contraception

For male participants: agreement to remain abstinent or use a condom

Disqualifiers

Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)

Prior treatment with elranatamab

Prior allogeneic stem cell transplantation (SCT)

Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Safety Lead-In CohortExperimental treatment 3 interventions
Group B: Dose Expansion Cohort (Combined Therapy)Experimental treatment 3 interventions
Group C: Dose Expansion Cohort (Monotherapy)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With Adverse Events (AEs)

Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). The severity of CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) and hemophagocytic lymphohistiocytosis (HLH) will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) Grading Scales.

Time frame
From signing of informed consent up to end of study (EOS) (approximately 36 months)
2

Recommended Phase II Regimen (RP2R)

Time frame
Up to approximately 36 months

Secondary outcomes

1

Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria

Time frame
Up to approximately 36 months
2

Complete Response (CR)/ Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria

Time frame
Up to approximately 36 months
3

Rate of Very Good Partial Response (VGPR) or Better, as Determined by the Investigator per IMWG Criteria

Time frame
Up to approximately 36 months
4

Progression-Free Survival as Determined by the Investigator per IMWG Criteria

Time frame
Up to approximately 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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