Evaluating a new combination treatment for relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and tolerability of combining cevostamab and elranatamab in patients with relapsed or refractory multiple myeloma. It includes a safety lead-in stage followed by an expansion stage to determine the recommended Phase II dose for the treatment. Participants will be monitored for pharmacokinetics and overall activity of the drug combination. The study is designed to provide insights into the effectiveness of this novel treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Royal Prince Alfred Hospital
  Camperdown, New South Wales, Australia Recruiting
• Calvary Mater Newcastle
  Waratah, New South Wales, Australia Recruiting
• Royal Adelaide Hospital;Haematology Clinical Trials Unit
  Adelaide, South Australia, Australia Recruiting
• St. Vincent's Hospital Melbourne
  Melbourne, Victoria, Australia Recruiting
• The Alfred Hospital
  Prahan, Victoria, Australia Recruiting
• The Chaim Sheba Medical Center - PPDS
  Ramat Gan, Central District, Israel Recruiting

Study contacts

• Study coordinator: GO43979 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma

  This study tests if Cevostamab combined with pomalidomide and dexamethasone can help people with multiple myeloma who have already had CAR T therapy and several prior treatments.

  Recruiting at 5 sites Phase 2 Hoffmann-La Roche · Nuremberg, Bavaria and 4 other locations · NCT07825064

• AZD4045 in Relapsed or Refractory Multiple Myeloma

  This study tests AZD4045 alone and with daratumumab and aldesleukin in adults whose multiple myeloma has returned or stopped responding to treatment.

  Recruiting at 3 sites Phase 1/2 AstraZeneca · Duarte, California and 11 other locations · NCT07681596

• Elranatamab consolidation for newly diagnosed plasmablastic lymphoma

  This study tests whether giving Elranatamab after initial chemotherapy can help patients with plasmablastic lymphoma, with or without HIV, stay in remission.

  Recruiting Phase 1 University of Illinois Chicago · Chicago, Illinois · NCT07647432

• Elranatamab given as outpatient in relapsed or refractory multiple myeloma

  This study tests a bispecific antibody called elranatamab, given in an outpatient setting to adults with relapsed or refractory multiple myeloma who have had prior therapies.

  Recruiting at 6 sites Phase 2 SCRI Development Innovations, LLC · Denver, Colorado and 5 other locations · NCT07637578

• Cevostamab in systemic lupus erythematosus with or without active lupus nephritis

  This study tests cevostamab in people with systemic lupus erythematosus, with or without active lupus nephritis, to see how safe it is and how the body handles it when added to standard care.

  Recruiting at 11 sites Phase 1 Genentech, Inc. · Parkville, Victoria and 10 other locations · NCT07629583

• A new treatment approach for relapsed or refractory multiple myeloma in adults

  This study tests if IBI3003 works better than the investigator's choice treatment for adults whose multiple myeloma has returned or persisted after prior therapy.

  Recruiting Phase 3 Innovent Biologics (Suzhou) Co. Ltd. · Shanghai, Shanghai Municipality · NCT07623798

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.