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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
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.
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|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Hoffmann-La Roche|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Korea, Republic of, Poland, Spain|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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.
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.
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.
Severance Hospital, Yonsei University Health System
Seoul, , 003-722
Samsung Medical Center
Seoul, , 135-710
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
Gdansk, , 80-952
Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, , 10-228
Not yet recruiting
Fundacion Jimenez Diaz; Servicio de Hematologia
Madrid, , 28040