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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma (NCT05583617) is a Phase 1 / Phase 2 interventional studying Multiple Myeloma, sponsored by Hoffmann-La Roche. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Multiple Myeloma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 200 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Multiple Myeloma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) - 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 Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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 * 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

Treatments Being Tested

DRUG

Cevostamab

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.

DRUG

Lenalidomide

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

DRUG

Tocilizumab

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

DRUG

Iberdomide

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

DRUG

Dexamethasone

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

Locations (16)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Prince of Wales Hospital
Randwick, New South Wales, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
CHU Lyon Sud - Service Hématologie
Pierre-Bénite, France
IUCT Oncopole
Toulouse, France
Hopital Bretonneau
Tours, France
IGR
Villejuif, France
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg, Germany
Universitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie
Leipzig, Germany
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland
Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, Poland
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05583617), the sponsor (Hoffmann-La Roche), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05583617 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05583617?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05583617?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05583617. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05583617. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.