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Tests treatment safety and results for Relapsed or Refractory Multiple Myeloma
Official title 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)
ClinicalTrials.gov ID: NCT05927571
What this study is testing
What is Cevostamab?
Cevostamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Camperdown, New South Wales, Australia
- Waratah, New South Wales, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Prahan, Victoria, Australia
- Ramat Gan, Central District, Israel
- Haifa, Israel
- Jerusalem, Israel
- Tel Aviv, Israel
- Seocho, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camperdown, New South Wales, Australia; Waratah, New South Wales, Australia; Adelaide, South Australia, Australia; Melbourne, Victoria, Australia; Prahan, Victoria, Australia; Ramat Gan, Central District, Israel and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.