Multiple Myeloma
Conditions
Interventions
Daratumumab
Arm A: Teclistamab-daratumumab (Tec-Dara)
Arm B:Daratumumab,Pomalidomide,Dexamethasone (DPd) or Daratumumab, Bortezomib,Dexamethasone (DVd)
Daratumumab will be administered SC injection.
Sponsors
Yamazaki Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio - Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion - Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen - Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment - Have clinical laboratory values within the specified range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include: a. A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG, b. A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization - Received any prior B cell maturation antigen (BCMA)-directed therapy - Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG - Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within 14 days before randomization - Received a live, attenuated vaccine within 4 weeks before randomization - Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) Up to 5 years PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response (Partial Response [PR] or Better) Up to 5 years Overall response (PR or better) is defined as participants who have a PR or better per IMWG criteria. Very Good Partial Response (VGPR) or Better Up to 5 years VGPR or better is defined as participants who achieve a VGPR or better response per IMWG criteria. Complete Response (CR) or Better Up to 5 years CR or better is defined as participants who achieve a CR or better response per IMWG criteria. Minimal Residual Disease (MRD)-negativity Up to 5 years MRD-negativity is defined as participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy. Progression Free Survival on Next-line Therapy (PFS2) Up to 5 years PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Overall Survival (OS) Up to 5 years OS is measured from the date of randomization to the date of the participant's death. Time to Next Treatment (TTNT) Up to 5 years TTNT is defined as the interval time from randomization to the start of subsequent antimyeloma treatment. Duration of Response Up to 5 years Duration of response will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria, or death due to any cause, whichever occurs first. Number of Participants with Adverse Events (AEs) by Severity Up to 5 years Number of participants with AEs by Severity will be reported. Serum Concentration of Teclistamab Up to 5 years Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive me | — |
Countries
Argentina, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea,Republic Of, Netherlands, Poland, Russian Federation, Spain, Sweden, Taiwan,Province Of China, Turkey, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed