Multiple Myeloma
Conditions
Interventions
Study treatment will be administered on 28-day cycles for Tec-Dara (Arm A) and
DPd (Arm B). For DVd (Arm B), study treatment will be administered on 21-day
cycles for Cycles 1 to 8 and 28-day cycles
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - >=18 years of age. - Documented multiple myeloma as defined by the criteria below: a. Multiple myeloma diagnosis according to the IMWG diagnostic criteria b. Measurable disease at screening as defined by any of the following: 1) Serum M-protein level >=0.5 g/dL (central laboratory); or 2) Urine M-protein level >=200 mg/24 hours (central laboratory); or 3) Serum immunoglobulin free light chain >=10 mg/dL (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio. - Received 1 to 3 prior line(s) of antimyeloma therapy (Appendix 6) including a PI and lenalidomide. a. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory (ie, have demonstrated progressive disease by IMWG criteria during treatment or within 60 days of completion of lenalidomide-containing regimen). 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 ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment (Appendix 7). - Have clinical laboratory values meeting the criteria specified in the protocol.
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 DPd as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide (intolerance defined as prior therapy discontinued due to any AE related to pomalidomide) 2) Disease that is considered refractory to pomalidomide per IMWG (progression during treatment or within 60 days of completing treatment with pomalidomide). b. A participant is not eligible to receive DVd as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib (intolerance defined as prior therapy discontinued due to any AE related to bortezomib) 2) Grade 1 peripheral neuropathy with pain or Grade >=2 peripheral neuropathy as defined by NCI-CTCAE Version 5.0 3) Disease that is considered refractory to bortezomib per IMWG (progression during treatment or within 60 days of completing treatment with bortezomib). 4) Received a strong CYP3A4 inducer (see Section 6.12.3.3) within 5 half-lives prior to randomization. c. A participant is not eligible for this study if they are refractory to both pomalidomide and bortezomib. - Received any prior BCMA-directed therapy. - Has disease that is considered refractory to an anti-CD38 monoclonal antibody per IMWG (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody). - 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, Waldenström*s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis. For a full list of exclusion criteria, please refer to section 5.2 of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare the efficacy of teclistamab in combination with daratumumab SC (Tec-Dara; Arm A) with that of an investigator*s choice of DPd or DVd (Arm B; termed DPd/DVd hereafter) as assessed by PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary objectives include further comparison of efficacy as assessed by overall response (PR or better) rate, CR or better rate,MRD -negativity rate, PFS2, Overall survival, Time to next treatment and duration of response. | — |
Countries
Netherlands
Outcome results
None listed