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.
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||Genentech, Inc.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Canada, Czechia, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Single-Agent Cevostamab (Arm A)
Cohort A1S is a safety run-in arm evaluating cevostamab administered in 28-day cycles on a modified weekly schedule. Upon completion, Cohort A1E, an expansion cohort may be opened. Participants will be treated with single-agent cevostamab administered in 28-day cycles on a modified weekly schedule.
Experimental: Cevostamab plus Pomalidomide and Dexamethasone (Pd) (Arm B)
Participants will be treated with cevostamab monotherapy during a 15-day period prior to the start of pomalidomide treatment (cevostamab pre-phase). Cohort B1S is a safety run-in arm evaluating cevostamab and Pd administered in 28-day cycles every 2 weeks (Q2W) followed by every 4 weeks (Q4W) schedule. Upon completion, 2 expansion cohorts will be opened at dose level 1 (Cohort B1E) and at dose level 2 (Cohort B2E). They will follow the same Q2W/Q4W dosing schedule as Cohort B1S.
Experimental: Cevostamab plus Daratumumab and Dexamethasone (Dd) (Arm C)
Cohort C1S is a safety run-in arm evaluating cevostamab and Dd administered in 21 day cycles from Cycle(C)1 - C8 every 3 weeks (Q3W) and 28-day cycles from C9 onwards Q4W. Upon completion, 2 expansion cohorts will be opened at dose level 1 (Cohort C1E) and at dose level 2 (Cohort C2E). They will follow the same Q3W/Q4W dosing schedule as Cohort C1S.
Drug: - Cevostamab
Cevostamab will be administered intravenously on a 28-day cycle, up to a total of 13 cycles (Arm A), in 28-day cycles Q2W followed by Q4W (Arm B) and in 21 day cycles from C1-C8 Q3W and 28-day cycles from C9 onwards Q4W (Arm C). For Arms B and C, participants can be treated until disease progression or unacceptable toxicity.
Drug: - Tocilizumab
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Drug: - Pomalidomide
Pomalidomide will be administered orally (PO) on a 28-day cycle.
Drug: - Daratumumab
Daratumumab will be administered subcutaneously (SC) on 21 day (C1-8) and 28-day cycles (C9 onwards).
Drug: - Dexamethasone
Arm A: Dexamethasone will be administered as a premedication. Arms B and C: Dexamethasone will be administered via IV or orally at 20 mg as study investigational medicinal product.
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.