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

Recruiting now · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT05583617

Run by

Hoffmann-La Roche

People needed

200

Starts

2023-11-14

Expected to finish

2028-07-31

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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