ClinicalTrials.gg
RecruitingNCT04910568CAMMA 1Updated Oct 20, 2026

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

A Phase 1 interventional study of Cevostamab and Tocilizumab in Multiple Myeloma, sponsored by Genentech, Inc.. Recruiting at 34 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

02

Conditions studied

  • Multiple Myeloma

Browse trials for

03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 186 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 517 studies on the registry; 20 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.

First submitted after Genentech, Inc. became part of Hoffmann-La Roche.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (ECOG) Performance Status of 0 or 1
  • of at least 12 weeks
  • Agreement to provide bone marrow and aspirate samples
  • Resolution of adverse events from prior anti-cancer therapy to Grade \<=1
  • For women of : agreement to remain abstinent or use , 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
  • 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 , 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

Exclusion criteria

Exclusion Criteria:

  • 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, , 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
  • 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 ( or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
  • 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 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 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 virus (HBV) infection
  • Acute or chronic 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 seropositivity
  • Administration of a live, attenuated vaccine within 4 weeks before first study treatment or anticipation that such a will be required during the study
  • Treatment with systemic medications, with the exception of 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, 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 to prior treatment with immunomodulatory drugs such as thalidomide, lenalidomide, or pomalidomide
  • Inability to tolerate thromboprophylaxis, or 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 (COPD) with a (FEV1) \<50% of predicted normal
  • Known moderate or severe persistent asthma within the past 2 years, or current uncontrolled asthma of any classification
Terms in these criteria, in plain language(23)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
186 participants (estimated)

Study arms

  • Experimental
    Single-Agent Cevostamab (Arm A)

    Cohort 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.

    Drug: Cevostamab · Drug: Tocilizumab · Drug: Dexamethasone

  • Experimental
    Cevostamab plus Pomalidomide and Dexamethasone (Pd) (Arm B)

    Participants 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.

    Drug: Cevostamab · Drug: Tocilizumab · Drug: Pomalidomide · Drug: Dexamethasone

  • Experimental
    Cevostamab plus Daratumumab and Dexamethasone (Dd) (Arm C)

    Cohort 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.

    Drug: Cevostamab · Drug: Tocilizumab · Drug: Daratumumab · Drug: Dexamethasone

Interventions

  • 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.

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

    Also known as: Actemra/RoActemra

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

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

  • 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.

06

What researchers measure

Primary outcomes

  1. Recommended Phase II Dose (RP2D)

    Time frame: Baseline up to approximately 4 years

  2. Percentage of Participants with Adverse Events

    Time frame: Baseline up to approximately 4 years

  3. Percentage of Dose Interruptions

    Time frame: Baseline up to approximately 4 years

  4. Percentage of Dose Reductions

    Time frame: Baseline up to approximately 4 years

  5. Percentage of Dose Intensity

    Time frame: Baseline up to approximately 4 years

  6. Percentage of Treatment Discontinuation

    Time frame: Baseline up to approximately 4 years

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Baseline up to approximately 4 years

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

    Time frame: Baseline up to approximately 4 years

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

    Time frame: Baseline up to approximately 4 years

  4. Progression-free Survival (PFS)

    Time frame: 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)

    Time frame: 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)

    Time frame: Baseline up to approximately 4 years

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

    Time frame: Baseline up to approximately 4 years

  8. Overall Survival (OS)

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

  9. Serum Concentration of Cevostamab at Specified Timepoints

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

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

    Time frame: CPP D1 up to approximately 4 years

  11. Maximum Observed Serum Concentration (Cmax) of Cevostamab

    Time frame: CPP D1 up to approximately 4 years

  12. Minimum Observed Serum Concentration (Cmin) of Cevostamab

    Time frame: CPP D1 up to approximately 4 years

  13. Clearance of Cevostamab

    Time frame: CPP D1 up to approximately 4 years

  14. Volume of Distribution at Steady State of Cevostamab

    Time frame: CPP D1 up to approximately 4 years

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

    Time frame: Baseline

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

    Time frame: Up to approximately 4 years

  17. Serum Concentration of Pomalidomide

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

  18. Serum Concentration of Daratumumab

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

07

Study locations

4 of 34 sites recruiting
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04910568
Lead sponsor
Genentech, Inc.
Collaborators
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jun 2, 2021
Start date
Jul 26, 2021
Primary completion
Dec 21, 2028 (estimated)
Completion
Dec 21, 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Reference Study ID Number: GO42552 https://forpatients.roche.com/No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Clinical Trials
study director · Genentech, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Cevostamab · Dexamethasone

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