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RECRUITINGPhase 1INTERVENTIONAL

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)

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body) - 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 weakened immune system virus (HIV) seropositivity - History of central nervous system (CNS) myeloma disease - Significant cardiovascular disease Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Cevostamab

Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.

DRUG

Elranatamab

Elranatamab solution for injection will be administered SC as specified in each treatment arm.

DRUG

Tocilizumab

Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

Locations (14)

Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Royal Adelaide Hospital;Haematology Clinical Trials Unit
Adelaide, South Australia, Australia
St. Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
The Alfred Hospital
Prahan, Victoria, Australia
Rambam Health Care Campus
Haifa, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel
Sheba Medical Center - PPDS
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, Israel
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Seocho, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center.
Seoul, South Korea
Samsung Medical Center - PPDS
Seoul, South Korea