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NCT Number: 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)

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.

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Key information

Conditions

Relapsed or Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cevostamab

Drug

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

Elranatamab

Drug

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

Tocilizumab

Drug

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

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: From signing of informed consent up to end of study (EOS) (approximately 36 months)

    Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). The severity of CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) and hemophagocytic lymphohistiocytosis (HLH) will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) Grading Scales.

  2. Recommended Phase II Regimen (RP2R)

    Time frame: Up to approximately 36 months

Secondary outcomes

  1. Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria

    Time frame: Up to approximately 36 months

  2. Complete Response (CR)/ Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria

    Time frame: Up to approximately 36 months

  3. Rate of Very Good Partial Response (VGPR) or Better, as Determined by the Investigator per IMWG Criteria

    Time frame: Up to approximately 36 months

  4. Progression-Free Survival as Determined by the Investigator per IMWG Criteria

    Time frame: Up to approximately 36 months

  5. 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

  6. Time to First Response (for Participants who Achieve a Response of PR or Better)

    Time frame: Up to approximately 36 months

  7. Time to Best Response (for Participants who Achieve a Response of PR or Better)

    Time frame: Up to approximately 36 months

  8. Overall Survival (OS)

    Time frame: Up to approximately 36 months

  9. Serum Concentration of Cevostamab at Specified Timepoints

    Time frame: Up to approximately 36 months

  10. Serum Concentration of Elranatamab at Specified Timepoints

    Time frame: Up to approximately 36 months

  11. Number of Participants with Anti-Drug Antibody (ADA) Against Cevostamab

    Time frame: Up to approximately 36 months

  12. Number of Participants with ADA Against Elranatamab

    Time frame: Up to approximately 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

GO43979 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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