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.
Cevos + Len substudy(SS) 2 (DIRAC): 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. Cevostamab + Iberdomide SS4 (CHAWLA): This substudy will evaluate the safety, tolerability, PK, and pharmacodynamics of the combination of cevostamab and iberdomide in participants with R/R MM who have received at least three prior lines of therapy, including a PI, an IMiD, and an anti-CD38 monoclonal antibody.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Substudy 2: Cevostamab will be administered intravenously (IV) on a 28-day cycle, up to a total of 13 cycles. Substudy 4: Cevostamab will be administered by IV on a 21-day cycle, up to a total of 17 cycles.
Lenalidomide will be administered PO on days 1-21 of a 28-day cycle.
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Prince of Wales Hospital
Randwick, New South Wales, Australia
RECRUITINGSt Vincent's Hospital Melbourne
Stage 1: Percentage of Participants with Adverse Events (AEs)
Time frame: Baseline up to approximately 5 years
Stage 2: Objective Response Rate (ORR)
Time frame: Baseline up to approximately 5 years
Stage 2: Complete Response (CR) or Stringent Complete Response (sCR) Rate
Time frame: Baseline up to approximately 5 years
Stage 2: Rate of Very Good Partial Response (VGPR) or Better
Time frame: Baseline up to approximately 5 years
Stage 2: Progression-free Survival (PFS)
Time frame: Baseline up to approximately 5 years
Stage 2: Overall Survival (OS)
Time frame: Baseline up to approximately 5 years
Stage 1: Conversion to a Better Response
Time frame: Baseline up to approximately 5 years
Stage 1: PFS
Time frame: Baseline up to approximately 5 years
Stages 1 and 2: Duration of Response (DOR)
Time frame: Baseline up to approximately 5 years
Stage 1: OS
Time frame: Baseline up to approximately 5 years
Stages 1 and 2: Minimal Residual Disease (MRD) Negativity Rate
Time frame: Baseline up to approximately 5 years
Reference Study ID Number: CO43923 https://forpatients.roche.com/ No attachments to email below.
CONTACT
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CONTACT
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Iberdomide will be administered PO on days 1-14 of a 21-day cycle.
Dexamethasone will be administered on Days 2 and 8 of Cycles 1-3.
Fitzroy, Victoria, Australia
CHU Lyon Sud - Service Hématologie
Pierre-Bénite, France
RECRUITINGIUCT Oncopole
Toulouse, France
RECRUITINGHopital Bretonneau
Tours, France
RECRUITINGIGR
Villejuif, France
WITHDRAWNUniversitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg, Germany
RECRUITINGUniversitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie
Leipzig, Germany
RECRUITINGUniwersyteckie Centrum Kliniczne
Gdansk, Poland
RECRUITINGOddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland
RECRUITING...and 6 more locations
Stage 1: ORR
Time frame: Baseline up to approximately 5 years
Stage 1: CR or sCR Rate
Time frame: Baseline up to approximately 5 years
Stage 1: Rate of VGPR or Better
Time frame: Baseline up to approximately 5 years
Stage 2: Stage 1: Percentage of Participants with AEs
Time frame: Baseline up to approximately 5 years
Stages 1 and 2: Time to First Response (for Participants who Achieve a Response of PR or Better)
Time frame: Baseline up to approximately 5 years
Stages 1 and 2: Time to Best Response (for Participants who Achieve a Response of PR or Better)
Time frame: Baseline up to approximately 5 years
Stages 1 and 2: Maximum Concentration Observed (Cmax)
Time frame: Baseline up to approximately 5 years
Stages 1 and 2: Minimum Concentration under Steady-State Conditions within a Dosing Interval (Cmin)
Time frame: Baseline up to approximately 5 years
Stages 1 and 2: Time to Maximum Concentration (Tmax)
Time frame: Baseline up to approximately 5 years
Stages 1 and 2: Area under the Concentration-Time Curve (AUC)
Time frame: Baseline up to approximately 5 years
Stages 1 and 2: Total Clearance of Drug (CL)
Time frame: Baseline up to approximately 5 years
Stages 1 and 2: Volume of Distribution at Steady State
Time frame: Baseline up to approximately 5 years
Stages 1 and 2: Terminal half-life
Time frame: Baseline up to approximately 5 years