Menu
Recruiting NCT05927571

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)

Phase I Interventional Relapsed or Refractory Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cevostamab, Elranatamab, Tocilizumab.
Who it may be relevant to
Registry conditions: Relapsed or Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Israel, South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Number of Participants With Adverse Events (AEs) [Time frame: From signing of informed consent up to end of study (EOS) (approximately 36 months)]
  • Recommended Phase II Regimen (RP2R) [Time frame: Up to approximately 36 months]
Secondary outcome measures (12)
  • Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria [Time frame: Up to approximately 36 months]
  • Complete Response (CR)/ Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria [Time frame: Up to approximately 36 months]
  • Rate of Very Good Partial Response (VGPR) or Better, as Determined by the Investigator per IMWG Criteria [Time frame: Up to approximately 36 months]
  • Progression-Free Survival as Determined by the Investigator per IMWG Criteria [Time frame: Up to approximately 36 months]
  • Duration of Response (DOR) as Determined by the Investigator (for Participants who Achieve a Response of Partial Response (PR) or Better) [Time frame: Up to approximately 36 months]
  • Time to First Response (for Participants who Achieve a Response of PR or Better) [Time frame: Up to approximately 36 months]
  • Time to Best Response (for Participants who Achieve a Response of PR or Better) [Time frame: Up to approximately 36 months]
  • Overall Survival (OS) [Time frame: Up to approximately 36 months]
  • Serum Concentration of Cevostamab at Specified Timepoints [Time frame: Up to approximately 36 months]
  • Serum Concentration of Elranatamab at Specified Timepoints [Time frame: Up to approximately 36 months]
  • Number of Participants with Anti-Drug Antibody (ADA) Against Cevostamab [Time frame: Up to approximately 36 months]
  • Number of Participants with ADA Against Elranatamab [Time frame: Up to approximately 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 5 centers
  • Royal Prince Alfred Hospital — Camperdown
  • Calvary Mater Newcastle — Waratah
  • Royal Adelaide Hospital;Haematology Clinical Trials Unit — Adelaide
  • St. Vincent's Hospital Melbourne — Melbourne
  • The Alfred Hospital — Prahan
South Korea · 5 centers
  • The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital) — Seocho
  • Seoul National University Hospital — Seoul
  • Severance Hospital, Yonsei University Health System — Seoul
  • Asan Medical Center. — Seoul
  • Samsung Medical Center - PPDS — Seoul
Israel · 4 centers
  • The Chaim Sheba Medical Center - PPDS — Ramat Gan
  • Rambam Health Care Campus — Haifa
  • Hadassah University Hospital - Ein Kerem — Jerusalem
  • Tel Aviv Sourasky Medical Center PPDS — Tel Aviv

Identifiers

NCT: NCT05927571 · GO43979 · 2023-504657-13-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗