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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Substudy 2:
  • - Completion of planned induction therapy and achievement of at least a partial response (PR) - Autologous Stem Cell Transplant (ASCT) 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 women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
  • - For men: 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.

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 Substudy 2:
  • - Severe hypersensitivity reactions to lenalidomide.
  • - 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) - Harbor lesions at proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare.
  • - Chronic treatment with more than 10 milligrams (mg)/day of corticosteroids.
The maximal authorized dose of corticosteroids in the study is 10 mg/day when not used to treat an AE or as a premedication for cevostamab dosing.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05583617
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

Cevos + Len substudy 2: 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.

Arms & Interventions

Arms

Experimental: Substudy 2: Escalation Phase

In Cycle 1, participants will receive 2 step-up doses and a target dose of cevostamab. The step-up dose will be given on Cycle(C) 1 Day(D)1 and C1D8. The target dose will be given on C1D15. Subsequently the target dose will be administered on D1 and D15 for cycles 2-6 and D1 of cycle 7 onwards. Each cycle is 28 days. Lenalidomide will be administered by mouth (PO) on a 28-day cycle.

Experimental: Substudy 2: Expansion Phase

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.

Interventions

Drug: - Cevostamab

Cevostamab will be administered intravenously on a 28-day cycle, up to a total of 13 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Seoul, Korea, Republic of

Status

Recruiting

Address

Severance Hospital, Yonsei University Health System

Seoul, , 03722