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RecruitingLast updated: 11 October 2024

This study is recruiting people with relapsed or refractory multiple myeloma to evaluate how safe, tolerable and effective a combination of immunotherapy treatments isAn Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

This study is evaluating how safe and tolerable the combination of two immunotherapy drugs (cevostamab and elranatamab) are, and will also determine the recommended Phase 2 dose (RP2D) of this combination. The study consists of a safety lead-in stage, and an expansion stage.

Participants will receive cevostamab, given intravenously (IV), in combination with elranatamab, given as an injection under the skin (also called subcutaenously or SC), with step-up dosing of each drug in pre-phase. Following this, they will receive elranatamab, at the assigned dose as an SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as an IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.

Conditions

This trial is treating people with relapsed or refractory multiple myeloma

Eligibility

Inclusion

  • 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

Exclusion

  • 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
  • Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome
  • Participants with known history of amyloidosis
  • History of autoimmune disease
  • History of confirmed progressive multifocal leukoencephalopathy
  • Peripheral motor polyneuropathy of prespecified grade
  • Known or suspected chronic cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) infection
  • Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
  • Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Human immunodeficiency virus (HIV) seropositivity
  • History of central nervous system (CNS) myeloma disease
  • Significant cardiovascular disease

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Genentech, Inc.

Scientific Title

An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma

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