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Multiple MyelomaPhase 1/2PLYCOMNCT05583617

A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma

A Phase 1/2 study testing Cevostamab, Lenalidomide and Tocilizumab in people with Multiple Myeloma, run by Hoffmann-La Roche at 16 sites in 6 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

CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with 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, Lenalidomide and Tocilizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
16 sitesin 6 countries
Study dates
14 Nov 2023to 31 Jul 2028
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

  • Diagnosed with MM per International Myeloma Working Group (IMWG) criteria
  • Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2
  • Resolution of AEs from prior anti-cancer therapy to Grade <=1
  • Agreement to undergo scheduled assessments and procedures
  • Additional Inclusion Criteria for SS2:
  • Completion of planned induction therapy and achievement of at least a partial response (PR)
Show all 14Show fewer
  • Autologous Stem Cell Transplant (SCT) within 100 days prior to first study treatment and the absence of progressive disease
  • Cytogenetic high-risk features at diagnosis
  • Treatment with any investigational medicinal products, systemic cancer therapies, immunotherapies received previously in CO43923 (any arms) within 5 half-lives or 3 weeks whichever is the shortest
  • Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom even if they have had a prior vasectomy, and agreement to refrain from donating sperm
  • Additional Inclusion Criteria for SS4:
  • Previously exposed to at least a PI, an IMiD, and an anti-CD38 antibody for the treatment of R/R MM for whom no suitable SOC therapy options are available

Who cannot join

  • Inability to comply with protocol-mandated hospitalization and procedures
  • History of confirmed progressive multifocal leukoencephalopathy
  • History of other malignancy within 2 years prior to screening
  • Current or past history of central nervous system (CNS) disease
  • Significant cardiovascular disease that may limit a participant's ability to adequately respond to a CRS event
  • Symptomatic active pulmonary disease or requiring supplemental oxygen
Show all 43Show fewer
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV antibiotics where the last dose of IV antibiotics was given within 14 days prior to first study treatment
  • Known or suspected chronic active Epstein-Barr virus (EBV) infection
  • 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 HIV seropositivity
  • Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live, attenuated vaccine will be required during the study
  • 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
  • Additional Exclusion Criteria for SS2:
  • Hypersensitivity reactions to lenalidomide or other immunomodulatory drugs
  • Harbor lesions at proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
  • Prior treatment with any investigational medicinal product, systemic cancer therapy, or immunotherapies in any arm of study CO43923 within 5 half-lives or 3 weeks, whichever is shorter
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment
  • History of erythema multiforme, Grade >=3 rash, or blistering following prior treatment with immunomodulatory derivatives
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment Exlcusion Criteria Applicable to SS2 and SS4
  • History of autoimmune disease
  • Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the first dose of the study drug (does not include pretreatment medication)
  • 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 EBV PCR or CMV PCR prior to first study treatment
  • Additional Exclusion Criteria for SS4:
  • Treatment with any investigational medicinal products, systemic cancer therapies, immunotherapies within 5 half-lives or 12 weeks before starting pre-phase
  • History of anaphylaxis or hypersensitivity, including >=Grade 3 rash, during prior treatment with IMiDs, dexamethasone, any CELMoDs, or the excipients contained in the formulations
  • Known anaphylaxis, allergies, hypersensitivity, or intolerance to boron or mannitol, hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies (or recombinant antibody-related fusion proteins), or human proteins, CRBN modulating agents or their excipients, or known sensitivity to mammalian-derived products
  • Administration of strong CYP3A modulators; administration of proton-pump inhibitors within 2 weeks of starting study treatment
  • Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
  • Concurrent administration of a strong inhibitor, modulator or inducer of cytochrome P450 (CYP3A4/5) (including within 14 days of initiating study treatment)
  • History of malignancies, other than MM, unless the subject has been free of the disease for >=5 years
  • Peripheral neuropathy >Grade 2
  • Prior treatment with cevostamab or another agent targeting FcRH5 or iberdomide
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment
  • History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash with eosinophilia and systemic symptoms
  • Treatment with systemic immunosuppressive medications
  • Prior treatment with CAR T-cell therapy (autologous or allogeneic) within 12 weeks before starting pre-phase
  • Autologous SCT within 100 days prior to starting pre-phase
  • Prior allogeneic SCT
  • Plasmacytoma in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare

Trial locations and contacts

16 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: CO43923 https://forpatients.roche.com/ No attachments to email below. contact

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

global-roche-genentech-trials@gene.com

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

16 sites in 6 countries

France4 sites, 3 recruiting

  • CHU Lyon Sud - Service Hématologie

    Pierre-Bénite, 69310

    Recruiting

  • IUCT Oncopole

    Toulouse, 31059

    Recruiting

  • Hopital Bretonneau

    Tours, 37044

    Recruiting

  • IGR

    Villejuif, 94800

    Withdrawn

Other trials in France

Poland3 sites, 2 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Recruiting

  • Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10-228

    Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Późna, 60-569

    Withdrawn

Other trials in Poland

Spain3 sites, 3 recruiting

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08915

    Recruiting

  • Fundacion Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

Australia2 sites, 2 recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

    Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

    Recruiting

Other trials in Australia

Germany2 sites, 2 recruiting

  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

    Hamburg, 20246

    Recruiting

  • Universitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie

    Leipzig, 04103

    Recruiting

Other trials in Germany

South Korea2 sites, 2 recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

Other trials in South Korea

About this study

Official title: A Platform Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients With Multiple Myeloma

CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.

Read the detailed description

Cevos + Len substudy(SS) 2 (DIRAC):

This substudy will explore the combination of cevostamab and lenalidomide as post-transplant maintenance therapy in participants with MM with high-risk cytogenetic features who experienced at least a partial response (PR) after induction.

Cevostamab + Iberdomide SS4 (CHAWLA):

This substudy will evaluate the safety, tolerability, PK, and pharmacodynamics of the combination of cevostamab and iberdomide in participants with R/R MM who have received at least three prior lines of therapy, including a PI, an IMiD, and an anti-CD38 monoclonal antibody.

Being tested
Cevostamab, Lenalidomide, Tocilizumab, Iberdomide, Dexamethasone
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

    Substudy 2: Cevostamab will be administered intravenously (IV) on a 28-day cycle, up to a total of 13 cycles.

    Substudy 4: Cevostamab will be administered by IV on a 21-day cycle, up to a total of 17 cycles.

  • LenalidomideDrug

    Lenalidomide will be administered PO on days 1-21 of a 28-day cycle.

  • TocilizumabDrug

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

  • IberdomideDrug

    Iberdomide will be administered PO on days 1-14 of a 21-day cycle.

  • DexamethasoneDrug

    Dexamethasone will be administered on Days 2 and 8 of Cycles 1-3.

Study groups in NCT05583617
Study groupRoleWhat they receive
Substudy 2: Dose Escalation and ExpansionExperimentalIn the pre-phase, participants will receive 2 step-up doses and a target dose of cevostamab. The step-up dose will be given on Day(D)1 and D4. The target dose will be given on D8. Subsequently the target dose will be administered on D1 and D15 for cycles 1-6 and D1 of cycle 7 onwards. Each cycle is 28 days. Lenalidomide will be administered by mouth (PO) on a 28-day cycle. During the dose expansion phase, cevostamab will be administered following the same dosing schedule as the dose escalation phase. The target dose will be determined after the escalation phase. Lenalidomide will be administered PO on a 28-day cycle. Enrollment for Substudy 2 has closed.
Receives: Drug: Cevostamab; Drug: Lenalidomide; Drug: Tocilizumab
Substudy 4: Dose Escalation and ExpansionExperimentalIn the pre-phase, participants will receive 2 step-up doses and a target dose of cevostamab. The step-up dose will be given on D1 and D4. The target dose will be given on D8. Subsequently the target dose will be administered on D1 of each cycle, every 3 weeks (Q3W). Each cycle is 21 days. Iberdomide will be administered PO on a 21-day cycle. During the dose expansion phase, cevostamab will be administered following the same dosing schedule as the dose escalation phase. The target dose will be determined after the escalation phase. Iberdomide will be administered PO on a 21-day cycle.
Receives: Drug: Cevostamab; Drug: Tocilizumab; Drug: Iberdomide; Drug: Dexamethasone

What is being measured

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

  1. Stage 1: Percentage of Participants with Adverse Events (AEs)

    Measured: Baseline up to approximately 5 years

  2. Stage 2: Objective Response Rate (ORR)

    Measured: Baseline up to approximately 5 years

  3. Stage 2: Complete Response (CR) or Stringent Complete Response (sCR) Rate

    Measured: Baseline up to approximately 5 years

  4. Stage 2: Rate of Very Good Partial Response (VGPR) or Better

    Measured: Baseline up to approximately 5 years

  5. Stage 2: Progression-free Survival (PFS)

    Measured: Baseline up to approximately 5 years

  6. Stage 2: Overall Survival (OS)

    Measured: Baseline up to approximately 5 years

Secondary outcomes (18)

  1. Stage 1: Conversion to a Better Response

    Measured: Baseline up to approximately 5 years

  2. Stage 1: PFS

    Measured: Baseline up to approximately 5 years

  3. Stages 1 and 2: Duration of Response (DOR)

    Measured: Baseline up to approximately 5 years

  4. Stage 1: OS

    Measured: Baseline up to approximately 5 years

  5. Stages 1 and 2: Minimal Residual Disease (MRD) Negativity Rate

    Measured: Baseline up to approximately 5 years

  6. Stage 1: ORR

    Measured: Baseline up to approximately 5 years

  7. Stage 1: CR or sCR Rate

    Measured: Baseline up to approximately 5 years

  8. Stage 1: Rate of VGPR or Better

    Measured: Baseline up to approximately 5 years

  9. Stage 2: Stage 1: Percentage of Participants with AEs

    Measured: Baseline up to approximately 5 years

  10. Stages 1 and 2: Time to First Response (for Participants who Achieve a Response of PR or Better)

    Measured: Baseline up to approximately 5 years

  11. Stages 1 and 2: Time to Best Response (for Participants who Achieve a Response of PR or Better)

    Measured: Baseline up to approximately 5 years

  12. Stages 1 and 2: Maximum Concentration Observed (Cmax)

    Measured: Baseline up to approximately 5 years

  13. Stages 1 and 2: Minimum Concentration under Steady-State Conditions within a Dosing Interval (Cmin)

    Measured: Baseline up to approximately 5 years

  14. Stages 1 and 2: Time to Maximum Concentration (Tmax)

    Measured: Baseline up to approximately 5 years

  15. Stages 1 and 2: Area under the Concentration-Time Curve (AUC)

    Measured: Baseline up to approximately 5 years

  16. Stages 1 and 2: Total Clearance of Drug (CL)

    Measured: Baseline up to approximately 5 years

  17. Stages 1 and 2: Volume of Distribution at Steady State

    Measured: Baseline up to approximately 5 years

  18. Stages 1 and 2: Terminal half-life

    Measured: Baseline up to approximately 5 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 Oct 2022
  2. Study start14 Nov 2023
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05583617
Sponsor's protocol ID
CO43923
Other IDs
2021-005918-34, 2023-504484-16-00, 2023
Acronym
PLYCOM
Status last verified
Oct 2026
First submitted
14 Oct 2022
Last updated
6 Oct 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, Lenalidomide and Tocilizumab in people with Multiple Myeloma, run by Hoffmann-La Roche at 16 sites in 6 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 14 inclusion and 43 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 6 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 16 sites in France, Poland, Spain, Australia, Germany and 1 more country. 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?

Contact Reference Study ID Number: CO43923 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?

Stage 1: Percentage of Participants with Adverse Events (AEs) (time frame: Baseline up to approximately 5 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 NCT05583617.

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 6 Oct 2026.

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