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Multiple MyelomaPhase 1CAMMA 1NCT04910568

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

A Phase 1 study testing Cevostamab, Tocilizumab and Pomalidomide in people with Multiple Myeloma, run by Genentech, Inc. at 34 sites in 13 countries.

Recruiting

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

Sites and contacts
Official record
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Trial summary

This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with… 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, Tocilizumab and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
34 sitesin 13 countries
Study dates
26 Jul 2021to 21 Dec 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

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Agreement to provide bone marrow biopsy and aspirate samples
  • Resolution of adverse events from prior anti-cancer therapy to Grade <=1
  • Measurable disease
  • For women of childbearing potential: agreement to remain abstinent or use contraception, during the treatment period (including treatment interruptions) and for at least 5 months after the last dose of cevostamab and at least 3 months after the last dose of tocilizumab was administered
Show all 18Show fewer
  • For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, during the treatment period, and for at least 2 months after the last dose of tocilizumab was administered to avoid exposing the embryo and sexual partner Additional Arm A-Specific Inclusion Criteria
  • Diagnosis of R/R MM for which no established therapy for MM is appropriate and available, or intolerance to those established therapies Additional Arm B-Specific Inclusion Criteria
  • For Cohort B1S: Participants with R/R MM who have received at least two prior lines of treatment, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
  • For Cohort B2S, B1E, B3E: Participants with R/R MM who have received at least one prior line of treatment that included at least two consecutive cycles of treatment, including a PI and an IMiD
  • For Cohort B4E: Participants with R/R MM who have received one to four lines of prior therapy that included at least two consecutive cycles of anti-CD38 therapy, lenalidomide and a PI, and either: Prior B-cell maturation antigen- (BCMA)-targeted therapy-directed chimeric antigen receptor T (CAR T) cell therapy or Prior BCMA-antibody-drug conjugate (ADC) therapy
  • Agreement to comply with all requirements of the pomalidomide pregnancy prevention program
  • For women of childbearing potential: agreement to remain abstinent or use two reliable methods of contraception starting at least 4 weeks prior to, during the treatment period, and for at least 4 weeks after the last dose of pomalidomide was administered
  • For men: agreement to remain abstinent or use a condom during the treatment period and for at least 4 weeks after the last dose of pomalidomide, (even if he has undergone a successful vasectomy) and agreement to refrain from donating sperm and blood during this same period Additional Arm C-Specific Inclusion Criteria
  • For Cohort C1S: Patients with R/R MM who have received at least two prior lines of treatment including a PI and an IMiD
  • For Cohort C2S and additional cohorts: Participants with R/R MM who have received at least 1 prior line of therapy
  • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods during the treatment period and for at least 102 days after the last dose of daratumumab was administered
  • For men: agreement to remain abstinent or use a condom during the treatment period and for at least 102 days after the last dose of daratumumab was administered to avoid exposing the embryo, and agreement to refrain from donating sperm during this same period

Who cannot join

  • Prior treatment with cevostamab or another agent targeting FcRH5
  • Inability to comply with protocol-mandated hospitalization and activities restrictions
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the last dose of cevostamab or within 3 months after the last dose of tocilizumab (if applicable).
  • Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drugconjugate 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-CTLA4, anti-PD-1, and antiPD-L1 therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first study treatment
  • Prior treatment with CAR T-cell therapy within 12 weeks before first study treatment
Show all 44Show fewer
  • Treatment with radiotherapy within 4 weeks (systemic radiation) or 14 days (focal radiation) prior to first study treatment
  • Treatment with any chemotherapeutic agent or other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
  • Autologous SCT within 100 days prior to first study treatment
  • Prior allogeneic stem cell transplant(ation) (SCT)
  • Circulating plasma cell count exceeding 500/micro L 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 monoclonal antibody 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
  • Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors
  • 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
  • Symptomatic active pulmonary disease or requiring supplemental oxygen
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
  • Known or suspected chronic active Epstein-Barr virus (EBV) infection
  • 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 Grade >= 3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies
  • Known history of hemophagocytic lymphohistiocytosis (HLH) or immune effector cell associated hemophagocytic lymphohistiocytosis like syndrome (IEC HS)
  • Active symptomatic coronavirus disease 2019 (COVID-19) infection at study enrollment or requiring treatment with intravenous (IV) antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment. Patients 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 EBV polymerase chain reaction (PCR) or Cytomegalovirus (CMV) PCR prior to first study treatment
  • Known history of 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 Additional Arm B-Specific Exclusion Criteria
  • Pregnant or breastfeeding, or intending to become pregnant 4 weeks prior to initiation of study treatment, during the study, (including treatment interruptions) or within 4 weeks after the last dose of pomalidomide
  • Significant cardiovascular disease (such as, but not limited to, New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 12 months, uncontrolled arrhythmias, or unstable angina)
  • History of erythema multiforme, Grade >=3 rash, blistering, or severe hypersensitivity to prior treatment with immunomodulatory drugs such as thalidomide, lenalidomide, or pomalidomide
  • Inability to tolerate thromboprophylaxis, or contraindication to thromboprophylaxis
  • GI disease that might significantly alter absorption of oral drugs Additional Arm C-Specific Exclusion Criteria
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 102 days after the last dose of daratumumab
  • Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of daratumumab formulations
  • Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal
  • Known moderate or severe persistent asthma within the past 2 years, or current uncontrolled asthma of any classification

Trial locations and contacts

34 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: GO42552 https://forpatients.roche.com/No attachments to email below. contact

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

global-roche-genentech-trials@gene.com

34 sites in 13 countries

United States6 sites, 1 recruiting

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

    Withdrawn

  • Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center

    Denver, Colorado, 80218

    Recruiting

  • Karmanos Cancer Institute.

    Detroit, Michigan, 48201

    Completed

  • City of Hope

    Duarte, California, 91010

    Active, not recruiting

  • City of Hope - Lennar Foundation Cancer Center

    Irvine, California, 92618

    Active, not recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Active, not recruiting

Other trials in United States

Japan4 sites

  • Nagoya City University Hospital

    Aichi, 467-8602

    Withdrawn

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

    Withdrawn

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

    Withdrawn

  • Yamagata University Hospital

    Yamagata, 990-9585

    Active, not recruiting

Other trials in Japan

Canada3 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Active, not recruiting

  • Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

    Active, not recruiting

  • University Health Network

    Toronto, Ontario, M5G 2M9

    Active, not recruiting

Other trials in Canada

France3 sites

  • Hôpital Saint-Louis

    Paris, 75475

    Withdrawn

  • CHU de Poitiers - La Miletrie

    Poitiers, 86021

    Active, not recruiting

  • CHU Pontchaillou

    Rennes, 35003

    Withdrawn

Other trials in France

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Withdrawn

  • Pratia Onkologia Katowice

    Katowice, 41-500

    Active, not recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Późna, 60-569

    Withdrawn

Other trials in Poland

Australia2 sites, 1 recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3002

    Active, not recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Recruiting

Other trials in Australia

Czechia2 sites

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52

    Active, not recruiting

  • I Interni klinika

    Prague, 128 08

    Withdrawn

Other trials in Czechia

Israel2 sites, 1 recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Active, not recruiting

  • Sourasky Medical Centre

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Italy2 sites

  • Asst Papa Giovanni Xxiii

    Bergamo, Lombardy, 24127

    Active, not recruiting

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

    Brescia, Lombardy, 25123

    Completed

Other trials in Italy

South Korea2 sites

  • Seoul National University Hospital

    Seoul, 03080

    Active, not recruiting

  • Samsung Medical Center

    Seoul, 06351

    Active, not recruiting

Other trials in South Korea

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Active, not recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009

    Active, not recruiting

Other trials in Spain

United Kingdom2 sites, 1 recruiting

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA

    Recruiting

  • Royal Marsden Hospital

    Sutton, SW3 6JJ

    Active, not recruiting

Other trials in United Kingdom

Denmark1 site

  • Rigshospitalet

    København Ø, 2100

    Active, not recruiting

Other trials in Denmark

About this study

Official title: An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab as Monotherapy and Cevostamab Plus Pomalidomide and Dexamethasone or Cevostamab Plus Daratumumab and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

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 28-day cycle, up to a total of 13 cycles (Arm A), in 28-day cycles Q2W followed by Q4W (Arm B) and in 21 day cycles from C1-C8 Q3W and 28-day cycles from C9 onwards Q4W (Arm C). For Arm A, participants have the option to enter re-treatment within 12 months of the end of treatment visit. For Arms B and C, participants can be treated until disease progression or unacceptable toxicity.

  • TocilizumabDrug

    Also called Actemra/RoActemra

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

  • PomalidomideDrug

    Pomalidomide will be administered orally (PO) on a 28-day cycle.

  • DaratumumabDrug

    Daratumumab will be administered subcutaneously (SC) on 21 day (C1-8) and 28-day cycles (C9 onwards).

  • DexamethasoneDrug

    Arm A: Dexamethasone will be administered as a premedication.

    Arms B and C: Dexamethasone will be administered via IV or orally at 20 mg as study investigational medicinal product.

Study groups in NCT04910568
Study groupRoleWhat they receive
Single-Agent Cevostamab (Arm A)ExperimentalCohort A1S is a safety run-in arm evaluating cevostamab administered in 28-day cycles on a modified weekly schedule. Cohort A1E, an expansion cohort, has been opened and finished enrolling participants. Participants will be treated with single-agent cevostamab administered in 28-day cycles on a modified weekly schedule.
Receives: Drug: Cevostamab; Drug: Tocilizumab; Drug: Dexamethasone
Cevostamab plus Pomalidomide and Dexamethasone (Pd) (Arm B)ExperimentalParticipants will be treated with cevostamab monotherapy during a 14-day period prior to the start of pomalidomide treatment (cevostamab pre-phase). Cohort B1S is a safety run-in arm evaluating cevostamab and Pd administered in 28-day cycles every 2 weeks (Q2W) followed by every 4 weeks (Q4W) schedule. Additional safety run-in cohort(s) with lower target dose levels of cevostamab may be opened prior to opening the expansion cohorts. Two target dose levels of target dose level 1 (DL1) and lower dose level -1 (DL-1) of cevostamab will be selected for randomization in expansion cohorts (Cohorts B1E and B3E). An additional non-randomized expansion cohort (Cohort B4E) will be included. Expansion cohorts will follow the same Q2W/Q4W dosing schedule as Cohort B1S.
Receives: Drug: Cevostamab; Drug: Tocilizumab; Drug: Pomalidomide; Drug: Dexamethasone
Cevostamab plus Daratumumab and Dexamethasone (Dd) (Arm C)ExperimentalCohort C1S is a safety run-in arm evaluating cevostamab and Dd administered in 21 day cycles from Cycle(C)1 - C8 every 3 weeks (Q3W) and 28-day cycles from C9 onwards Q4W. Additional safety run-in cohort(s) with lower target dose levels of cevostamab may be opened prior to opening the expansion cohorts. Two target dose levels of DL1 and DL-1 of cevostamab will be selected for randomization in expansion cohorts. Expansion cohorts will follow the same Q3W/Q4W dosing schedule as Cohort C1S.
Receives: Drug: Cevostamab; Drug: Tocilizumab; Drug: Daratumumab; Drug: Dexamethasone

What is being measured

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

  1. Recommended Phase II Dose (RP2D)

    Measured: Baseline up to approximately 4 years

  2. Percentage of Participants with Adverse Events

    Measured: Baseline up to approximately 4 years

  3. Percentage of Dose Interruptions

    Measured: Baseline up to approximately 4 years

  4. Percentage of Dose Reductions

    Measured: Baseline up to approximately 4 years

  5. Percentage of Dose Intensity

    Measured: Baseline up to approximately 4 years

  6. Percentage of Treatment Discontinuation

    Measured: Baseline up to approximately 4 years

Secondary outcomes (18)

  1. Objective Response Rate (ORR)

    Measured: Baseline up to approximately 4 years

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

    Measured: Baseline up to approximately 4 years

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

    Measured: Baseline up to approximately 4 years

  4. Progression-free Survival (PFS)

    Measured: Start of study treatment to first date of disease progression or death from any cause, whichever occurs first (up to approximately 4 years)

  5. Duration of Response (DOR)

    Measured: From first partial response (PR) or better until the first date of disease progression or death from any cause, whichever occurs first (up to approximately 4 years)

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

    Measured: Baseline up to approximately 4 years

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

    Measured: Baseline up to approximately 4 years

  8. Overall Survival (OS)

    Measured: Baseline up until death from any cause (up to approximately 4 years)

  9. Serum Concentration of Cevostamab at Specified Timepoints

    Measured: Cevostamab Pre-Phase (CPP) Day (D) 1 up to approximately 3 years

  10. Total Exposure (Area Under the Concentration-time Curve [AUC]) of Cevostamab

    Measured: CPP D1 up to approximately 4 years

  11. Maximum Observed Serum Concentration (Cmax) of Cevostamab

    Measured: CPP D1 up to approximately 4 years

  12. Minimum Observed Serum Concentration (Cmin) of Cevostamab

    Measured: CPP D1 up to approximately 4 years

  13. Clearance of Cevostamab

    Measured: CPP D1 up to approximately 4 years

  14. Volume of Distribution at Steady State of Cevostamab

    Measured: CPP D1 up to approximately 4 years

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

    Measured: Baseline

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

    Measured: Up to approximately 4 years

  17. Serum Concentration of Pomalidomide

    Measured: From Cycle 1 Day 1 through Cycle 6 Day 15. Each cycle=28 days

  18. Serum Concentration of Daratumumab

    Measured: From C1D1 until disease progression or unexpected toxicity. Cycles 1-8 are 21 days and Cycle 9 onward are 28 days.

Timeline

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

  1. First posted2 Jun 2021
  2. Study start26 Jul 2021
  3. Primary completion21 Dec 2028 (estimated)
  4. Study completion21 Dec 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04910568
Sponsor's protocol ID
GO42552
Other IDs
2021-000238-33, 2023-507019-36-00, 2023
Acronym
CAMMA 1
Status last verified
Oct 2026
First submitted
27 May 2021
Last updated
20 Oct 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, Tocilizumab and Pomalidomide in people with Multiple Myeloma, run by Genentech, Inc. at 34 sites in 13 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 18 inclusion and 44 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Japan, Canada, France, Poland and 8 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 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 Reference Study ID Number: GO42552 https://forpatients.roche.com/No attachments to email below. (888-662-6728 (U.S. and Canada), 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?

Recommended Phase II Dose (RP2D) (time frame: Baseline up to approximately 4 years). The study lists 6 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 NCT04910568.

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 20 Oct 2026.

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