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NCT Number: NCT07558915

A Study to Evaluate RO7851624 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors [PIs], immunomodulators [IMiDs], and anti-cluster of differentiation 38 [anti-CD38] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.

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Key information

Conditions

Relapsed/Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases 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 Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peter MacCallum Cancer Center

Parkville, Victoria, 3052, Australia

Location status: Recruiting

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.
  • Life expectancy of at least 12 weeks.
  • Diagnosis of multiple myeloma per International Myeloma Working Group (IMWG) criteria.
  • Measurable disease.

Exclusion criteria

  • Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) with insufficient washout prior to first dose of study treatment.
  • Autologous stem cell transplant (SCT) with insufficient time prior to first dose of study treatment.
  • Prior allogeneic SCT.
  • Prior solid organ transplantation.

Treatment and study plan

RO7851624

Drug

Participants will receive RO7851624 as per the schedule described in the protocol.

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Serum Concentration of RO7851624

    Time frame: Up to approximately 2 years

  2. Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years

  3. Complete Response (CR) Rate/ Stringent Complete Response (sCR) Rate)

    Time frame: Up to approximately 2 years

  4. Rate of Very Good Partial Response (VGPR) Rate or Better

    Time frame: Up to approximately 2 years

  5. Progression-Free Survival (PFS)

    Time frame: Up to approximately 2 years

  6. Duration of Response (DOR)

    Time frame: Up to approximately 2 years

  7. Time to First Response

    Time frame: Up to approximately 2 years

  8. Time to Best Response

    Time frame: Up to approximately 2 years

  9. Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7851624 at Baseline and During the Study

    Time frame: Baseline, up to approximately 2 years

  10. Recommended Dose and Regimen of RO7851624

    Time frame: Up to approximately 2 years

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

Reference Study ID Number: GO46140 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

An Open-Label, Multicenter, Phase Ia/b Study Evaluating the Safety and Pharmacokinetics of RO7851624 in Patients With Relapsed/Refractory Multiple Myeloma

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Apr 30, 2026
Registry last updated
Jul 20, 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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