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Multiple MyelomaPhase 1NCT06934044

A Study Evaluating the Pharmacokinetics, Safety, and Efficacy of Cevostamab in Chinese Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1 study testing Cevostamab and Tocilizumab in people with Multiple Myeloma, run by Hoffmann-La Roche at 5 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will evaluate the pharmacokinetics (PK), safety, and efficacy of cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Cevostamab and Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesChina
Study dates
13 May 2025to 15 Nov 2028
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

  • Documented diagnosis of MM based on standard International Myeloma Working Group (IMWG) criteria
  • Evidence of progressive disease based on investigators determination of response by IMWG criteria on or after their last dosing regimen
  • Current relapsed or refractory (R/R) disease status
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Agreement to protocol-specified assessments, including bone marrow biopsy and aspirate samples as detailed in the protocol
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  • Resolution of AEs from prior anti-cancer therapy to Grade =< 1 or better
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 5 months after the final dose of cevostamab and for 3 months after the last dose of tocilizumab was administered
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 2 months after the final dose of tocilizumab (if applicable) to avoid exposing the embryo

Who cannot join

  • Unable to comply with protocol-mandated hospitalization
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of cevostamab or tocilizumab or within 3 months after the last dose of tocilizumab (if applicable)
  • Prior treatment with cevostamab or another agent with the same target
  • Prior use of any monoclonal antibody (mAb), radioimmunoconjugate, or ADC as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy
  • Prior treatment with systemic immunotherapeutic agents, including but not limited to, cytokine therapy and anti-CTLA-4, anti-PD-1, and anti-PD-L1
  • Prior treatment with CAR-T cell therapy within 12 weeks before first cevostamab infusion
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  • Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors
  • Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
  • Autologous stem cell transplantation (SCT) within 100 days prior to first study treatment
  • Prior allogeneic SCT
  • Prior solid organ transplantation
  • History of autoimmune disease
  • History of confirmed progressive multifocal leukoencephalopathy
  • History of severe allergic or anaphylactic reactions to mAb therapy
  • Known history of amyloidosis
  • Lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
  • History of other malignancy within 2 years prior to screening, except those with negligible risk of metastasis or death, such as ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer not requiring treatment or appropriately treated Stage I uterine cancer
  • Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM
  • Significant cardiovascular disease that may limit a potential participant's ability to adequately respond to a cytokine release syndrome (CRS) event
  • Symptomatic active pulmonary disease or requiring supplemental oxygen
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV (intravenous) antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment
  • Active symptomatic COVID-19 infection at study enrollment or requiring treatment with IV antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment.
  • Positive and quantifiable Epstein-Barr virus (EBV) polymerase chain reaction (PCR) or cytomegalovirus (CMV) PCR prior to first study treatment
  • Known or suspected chronic active EBV infection
  • Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
  • Known history of Grade >=3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies
  • Recent major surgery within 4 weeks prior to first study treatment
  • Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection
  • Acute or chronic hepatitis C virus (HCV) infection
  • Known history of human immunodeficiency virus (HIV) seropositivity
  • Administration of a live, attenuated vaccine within 4 weeks before first study treatment or anticipation that such a live attenuated vaccine will be required during the study
  • Treatment with systemic immunosuppressive medications, with the exception of corticosteroid treatment <= 10 mg/day prednisone or equivalent, within 2 weeks prior to first study treatment
  • History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
  • Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510555

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Tianjin Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality, 301636

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325035

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030

Other trials in China

About this study

Official title: A Phase Ib, Open-Label, Single-Arm, Multicenter Trial Evaluating the Pharmacokinetics, Safety, and Efficacy of Cevostamab in Chinese Patients With Relapsed or Refractory Multiple Myeloma

This study will evaluate the pharmacokinetics (PK), safety, and efficacy of cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM).

Being tested
Cevostamab, Tocilizumab
Medical subject headings
Multiple Myeloma

What participants receive

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

  • CevostamabDrug

    Cevostamab will be administered intravenously on a 21-day cycle.

  • TocilizumabDrug

    Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Study groups in NCT06934044
Study groupRoleWhat they receive
CevostamabExperimentalParticipants will receive cevostamab administered by intravenous (IV) infusion in 21-day cycles.
Receives: Drug: Cevostamab; Drug: Tocilizumab

What is being measured

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

  1. Serum Concentration of Cevostamab at Specified Timepoints

    Measured: Cycle 1 Day 1 (C1D1) up to approximately 2 years. Each cycle=21 days

  2. Percentage of Participants with Adverse Events

    Measured: Baseline up to approximately 2 years

Secondary outcomes (14)

  1. Objective Response Rate (ORR)

    Measured: Baseline up to approximately 2 years

  2. Rate of Complete Response (CR) or Better

    Measured: Baseline up to approximately 2 years

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

    Measured: Baseline up to approximately 2 years

  4. Duration of Response (DOR)

    Measured: Baseline up to approximately 2 years

  5. Progression-free Survival (PFS)

    Measured: Start of study treatment to first date of disease progression, relapse or death from any cause, whichever occurs first (up to approximately 2 years)

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

    Measured: Baseline up to approximately 2 years

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

    Measured: Baseline up to approximately 2 years

  8. Overall Survival (OS)

    Measured: Baseline up until death from any cause (up to approximately 2 years)

  9. Minimal Residual Disease (MRD) Negativity (for Participants who Achieve a Response of CR or Better)

    Measured: Baseline up to approximately 2 years

  10. MRD Negativity (for all Efficacy-evaluable Participants)

    Measured: Baseline up to approximately 2 years

  11. Number of Anti-drug Antibody (ADAs) Against Cevostamab at Baseline

    Measured: Baseline

  12. Percentage of Participants with ADAs Against Cevostamab During the Study

    Measured: Up to approximately 2 years

  13. Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Measured: Up to approximately 2 years

  14. Number of Participants Reporting Each Response Option for Treatment Side-effect Bother Single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General Questionnaire; (FACT-G)

    Measured: Up to approximately 2 years

Timeline

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

  1. First posted18 Apr 2025
  2. Study start13 May 2025
  3. Primary completion15 Nov 2028 (estimated)
  4. Study completion15 Nov 2028 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06934044
Sponsor's protocol ID
YO43835
Status last verified
Aug 2026
First submitted
9 Apr 2025
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cevostamab and Tocilizumab in people with Multiple Myeloma, run by Hoffmann-La Roche at 5 sites in China.

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 9 inclusion and 34 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Concentration of Cevostamab at Specified Timepoints (time frame: Cycle 1 Day 1 (C1D1) up to approximately 2 years. Each cycle=21 days). 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 NCT06934044.

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 28 Aug 2026.

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