Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP)
Participants will receive talquetamab and daratumumab as SC injections
dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)
Participants will receive d
dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)
Participants will receive talquetamab
dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Sponsors
Nakama Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio - Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed - Documented evidence of progressive disease based on investigator's determination of response by the 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 immediately prior to the start of administration of study treatment
Exclusion criteria
Exclusion criteria: - Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients - Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody) - Received prior pomalidomide therapy - A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug - Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required - Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) : Up to 6 years 6 months : PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response (Partial Response [PR] or Better) : Up to 6 years 6 months : Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria. Very Good Partial Response (VGPR) or Better Rate : Up to 6 years 6 months : VGPR or better rate is defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria. Complete Response (CR) or Better Rate : Up to 6 years 6 months : CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria. Overall Minimal Residual Disease (MRD) Negative Status : Up to 6 years 6 months : MRD-negative CR is defined as proportion of participants with CR or stringent CR who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy. Overall Survival (OS) : Up to 6 years 6 months : OS is defined as the time from the date of randomization to the date of the participant's death Progression-free Survival on Next-line Therapy (PFS2) : Up to 6 years 6 months : 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. Time to Next Therapy (TTNT) : Up to 6 years 6 months : TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. Number of Participants with Adverse Events (AEs) : Up to 6 years 6 months : An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Number of Participants with AEs by Severity : Up to 6 years 6 months : Severity will be graded according to | — |
Countries
Belgium, Brazil, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Korea,Republic Of, Netherlands, Poland, Spain, Taiwan, Turkey, UnitedKingdom Of Great Britain And NorthernIreland, UnitedStates Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed