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Relapsed or Refractory Multiple MyelomaPhase 1NCT05927571

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)

A Phase 1 study testing Cevostamab, Elranatamab and Tocilizumab in people with Relapsed or Refractory Multiple Myeloma, run by Genentech, Inc. at 14 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
Cevostamab, Elranatamab and Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
14 sitesin 3 countries
Study dates
10 Aug 2023to 31 Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

14 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

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

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

global-roche-genentech-trials@gene.com

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

14 sites in 3 countries

Australia5 sites, 5 recruiting

  • Royal Adelaide Hospital;Haematology Clinical Trials Unit

    Adelaide, South Australia, 5000

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

    Recruiting

  • St. Vincent's Hospital Melbourne

    Melbourne, Victoria, 3065

    Recruiting

  • The Alfred Hospital

    Prahan, Victoria, 3181

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Recruiting

Other trials in Australia

South Korea5 sites, 5 recruiting

  • The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)

    Seocho, 06591

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center.

    Seoul, 05505

    Recruiting

  • Samsung Medical Center - PPDS

    Seoul, 06351

    Recruiting

Other trials in South Korea

Israel4 sites, 4 recruiting

  • Rambam Health Care Campus

    Haifa, 3109600

    Recruiting

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

    Recruiting

  • The Chaim Sheba Medical Center - PPDS

    Ramat Gan, Central District, 5262100

    Recruiting

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

About this study

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

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.

Being tested
Cevostamab, Elranatamab, Tocilizumab
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CevostamabDrug

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

  • ElranatamabDrug

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

  • TocilizumabDrug

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

Study groups in NCT05927571
Study groupRoleWhat they receive
Safety Lead-In CohortExperimentalParticipants will receive cevostamab, intravenously (IV), in combination with elranatamab, subcutaneously (SC), with step-up dosing of each drug in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.
Receives: Drug: Cevostamab; Drug: Elranatamab; Drug: Tocilizumab
Dose Expansion Cohort (Combined Therapy)ExperimentalParticipants will receive cevostamab, IV, in combination with elranatamab, SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.
Receives: Drug: Cevostamab; Drug: Elranatamab; Drug: Tocilizumab
Dose Expansion Cohort (Monotherapy)ExperimentalParticipants will receive elranatamab SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity.
Receives: Drug: Elranatamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs)

    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.

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

  2. Recommended Phase II Regimen (RP2R)

    Measured: Up to approximately 36 months

Secondary outcomes (12)

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

    Measured: Up to approximately 36 months

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

    Measured: Up to approximately 36 months

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

    Measured: Up to approximately 36 months

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

    Measured: 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)

    Measured: Up to approximately 36 months

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

    Measured: Up to approximately 36 months

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

    Measured: Up to approximately 36 months

  8. Overall Survival (OS)

    Measured: Up to approximately 36 months

  9. Serum Concentration of Cevostamab at Specified Timepoints

    Measured: Up to approximately 36 months

  10. Serum Concentration of Elranatamab at Specified Timepoints

    Measured: Up to approximately 36 months

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

    Measured: Up to approximately 36 months

  12. Number of Participants with ADA Against Elranatamab

    Measured: Up to approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start10 Aug 2023
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05927571
Sponsor's protocol ID
GO43979
Other IDs
2023-504657-13-00, 2023
Status last verified
Nov 2026
First submitted
22 Jun 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cevostamab, Elranatamab and Tocilizumab in people with Relapsed or Refractory Multiple Myeloma, run by Genentech, Inc. at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Australia, South Korea, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GO43979 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: From signing of informed consent up to end of study (EOS) (approximately 36 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05927571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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