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Multiple MyelomaPhase 1/2CAMMA 2NCT05535244

A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma

A Phase 1/2 study testing Cevostamab and Tocilizumab in people with Multiple Myeloma, run by Hoffmann-La Roche at 27 sites in 8 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion. 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
90 participants
Where
27 sitesin 8 countries
Study dates
17 Oct 2022to 26 Feb 2027
Phase
Phase 1/2
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
  • Prior BCMA ADC or CAR-T Cohort: participants who have received a BCMA-targeted CAR-T or ADC therapy and are triple-class relapsed or refractory
  • Prior BCMA Bispecific Cohort: participants who have received a BCMA-targeting T-cell-dependent bispecific (TDB) antibody and are triple-class relapsed or refractory
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy is at least 12 weeks
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  • Agreement to protocol-specified assessments, including bone marrow biopsy and aspirate samples as detailed in the protocol
  • Resolution of AEs from prior anti-cancer therapy to Grade =< 1
  • 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

  • Inability 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 BCMA ADC or CAR-T Cohort: prior treatment with any T cell dependent bi-specific antibody (TDB) antibody including non BCMA targeting TDB
  • 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
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  • Prior treatment with CAR-T cell therapy within 12 weeks before first cevostamab infusion
  • 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
  • Circulating plasma cell count exceeding 500/ microliter (µL) or 5% of the peripheral blood white cells
  • 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. Participants with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart 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 Grade >=3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies
  • Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
  • 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

27 sites in 8 countries.

27 sites in 8 countries

United States9 sites

  • University of Colorado

    Aurora, Colorado, 80045-2517

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Mayo Clinic-Jacksonville

    Jacksonville, Florida, 32224

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203

  • Icahn School of Medicine at Mount Sinai (ISMMS)

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Hunstman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

Italy4 sites

  • Asst Papa Giovanni Xxiii

    Bergamo, Lombardy, 24127

  • Policlinico S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138

  • Fond. IRCCS Istituto Nazionale Tumori

    Milan, Lombardy, 20133

  • A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette

    Turin, Piedmont, 10126

Other trials in Italy

France3 sites

  • CHU NANTES - Hôtel Dieu

    Nantes, 44093

  • APHP - Hospital Saint Louis

    Paris, 75475

  • CHU de Poitiers - La Miletrie

    Poitiers, 86021

Other trials in France

Germany3 sites

  • Klinik der Uni zu Köln

    Cologne, 50924

  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

    Hamburg, 20246

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Israel3 sites

  • Hadassah Ein Karem Hospital

    Jerusalem, 9112001

  • Sheba Medical Center

    Ramat Gan, 5262100

  • Sourasky Medical Centre

    Tel Aviv, 6423906

Other trials in Israel

Australia2 sites

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

Spain2 sites

  • Hospital Clínic i Provincial

    Barcelona, 08036

  • Hospital Univ. 12 de Octubre

    Madrid, 28041

Other trials in Spain

Belgium1 site

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

About this study

Official title: A Phase I/II, Open-Label, Multi-Cohort Study to Evaluate the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen-Exposed Patients With Relapsed/Refractory Multiple Myeloma

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

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 by IV infusion in 21-day cycles.

  • TocilizumabDrug

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

Study groups in NCT05535244
Study groupRoleWhat they receive
Cohort A1: Prior BCMA antibody-drug conjugate (ADC) or chimeric antigen receptor T (CAR-T)ExperimentalParticipants in Cohort A1 will be treated at the double step-up split dosing regimen.
Receives: Drug: Cevostamab; Drug: Tocilizumab
Cohort A2: Prior BCMA BispecificExperimentalParticipants enrolled into exploratory Cohort A2 will receive the same dosing regimen as Cohort A1.
Receives: Drug: Cevostamab; Drug: Tocilizumab
Cohort B1: Prior BCMA CAR-TExperimentalParticipants enrolled in expansion Cohort B1, will be given cevostamab at the selected dosing regimen.
Receives: Drug: Cevostamab; Drug: Tocilizumab
Cohort B2: Prior BCMA BispecificExperimentalExpansion Cohort B2 will be opened, after the initial results from Cohort A2, at the same dose as per Cohort B1.
Receives: Drug: Cevostamab; Drug: Tocilizumab

What is being measured

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

  1. Objective Response Rate (ORR) as Determined by the Investigator

    Measured: Baseline up to approximately 2 years

  2. Percentage of Participants with Adverse Events

    Measured: Baseline up to approximately 2 years

Secondary outcomes (17)

  1. ORR as Determined by the Independent Review Committee (IRC)

    Measured: Baseline up to approximately 2 years

  2. Duration of Response (DOR)

    Measured: Baseline up to approximately 2 years

  3. Rate of Complete Response (CR) or Better

    Measured: Baseline up to approximately 2 years

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

    Measured: Baseline up to approximately 2 years

  5. Overall Survival (OS)

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

  6. Progression-free Survival (PFS)

    Measured: Baseline up to approximately 2 years

  7. Time to First Response (for Participants who Achieve an Objective Response)

    Measured: Baseline up to approximately 2 years

  8. Time to Best Response (for Participants who Achieve an Objective Response)

    Measured: Baseline up to approximately 2 years

  9. Percentage of Participants Experiencing a Clinically Meaningful Improvement in the Fatigue Domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core-30 Questionnaire (QLQ-C30) and EORTC QLQ-MY20

    Measured: Baseline up to approximately 2 years

  10. Time to Deterioration in the Fatigue Domain of the EORTC QLQ-C30 and/or Disease Symptoms Domain of the EORTC QLQ-MY20

    Measured: Baseline up to approximately 2 years

  11. Serum Concentration of Cevostamab at Specified Timepoints

    Measured: At Cycles 1, 2, 3, 4, 6, 8 and every other cycle until the end of treatment up to approximately 2 years. Each cycle is 21-days.

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

    Measured: Baseline

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

    Measured: Up to approximately 2 years

  14. Cytokine Release Syndrome (CRS) Following Administration of Tocilizumab

    Measured: Baseline up to approximately 2 years

  15. Relationship Between Serum Concentration of Cevostamab and Cytokine Release

    Measured: Baseline up to approximately 2 years

  16. Relationship Between Serum Concentration of Cevostamab and T Cell Number

    Measured: Baseline up to approximately 2 years

  17. Relationship Between Serum Concentration of Cevostamab and T-cell Activation State

    Measured: Baseline 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 posted10 Sep 2022
  2. Study start17 Oct 2022
  3. Primary completion26 Feb 2027 (estimated)
  4. Study completion26 Feb 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05535244
Sponsor's protocol ID
CO43476
Other IDs
2021-006816-10
Acronym
CAMMA 2
Status last verified
Nov 2026
First submitted
24 Aug 2022
Last updated
3 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 1/2 study testing Cevostamab and Tocilizumab in people with Multiple Myeloma, run by Hoffmann-La Roche at 27 sites in 8 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 10 inclusion and 36 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 3 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 27 sites in United States, Italy, France, Germany, Israel and 3 more countries. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Objective Response Rate (ORR) as Determined by the Investigator (time frame: Baseline up to approximately 2 years). 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 NCT05535244.

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 3 Nov 2026.

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