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New hope for myeloma patients as platform trial tests multiple treatments

NCT ID NCT05583617

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This study is testing several new drug combinations for people with multiple myeloma, a type of blood cancer. The trial is open to 200 participants who have already had some treatment. The goal is to see if these combinations are safe and help control the disease. Because multiple myeloma often requires ongoing treatment, this study focuses on disease control rather than a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Lyon Sud - Service Hématologie

    RECRUITING

    Pierre-Bénite, 69310, France

  • Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Hopital Bretonneau

    RECRUITING

    Tours, 37044, France

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitari Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 08915, Spain

  • IGR

    WITHDRAWN

    Villejuif, 94800, France

  • IUCT Oncopole

    RECRUITING

    Toulouse, 31059, France

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

    RECRUITING

    Olsztyn, 10-228, Poland

  • Prince of Wales Hospital

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • St Vincent's Hospital Melbourne

    RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie

    RECRUITING

    Leipzig, 04103, Germany

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    WITHDRAWN

    Późna, 60-569, Poland

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-214, Poland

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