At a glance
ClinicalIndex Comparison Record- ✓Measurable disease: serum M-protein ≥0.5 g/dL, urine M-protein ≥200 mg/24h, or light-chain disease with serum free light chain ≥10 mg/dL and abnormal ratio
- ✓1–3 prior lines of therapy including at least one proteasome inhibitor (PI) and one immunomodulatory drug (IMiD)
- ✓Progressive disease by IMWG criteria on or within 6 months of last regimen
- ✓Lenalidomide-refractory: failure to achieve minimal response or progression on or within 60 days of completing lenalidomide therapy in at least one prior line
- ✕Prior CAR-T therapy directed at any target
- ✕Any prior BCMA-targeted therapy
- ✕Unresolved toxicity from prior anticancer therapy (except alopecia)
- ✕Grade ≥2 peripheral neuropathy (or Grade 1 with pain) restricts PVd eligibility; DPd remains available
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma
In Brief
A Phase 3 clinical trial evaluating Cilta-cel, Pomalidomide, and 3 other interventions for Multiple Myeloma. Active but no longer recruiting, targeting 419 participants across 88 sites in 16 countries.
Signals
Detailed Summary
The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
Study Details
Timeline
Arms & Interventions
Participants will receive either PVd or DPd as a standard therapy. In PVd treatment, participants will receive oral pomalidomide 4 mg on Days 1 to 14 in each cycle; bortezomib 1.3 mg/meter square (m\^2) SC on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each cycle will consist of 21 days. In DPd treatment, participants will receive daratumumab SC 1800 mg weekly on Days 1, 8, 15, and 22 (Cycles 1 and 2), every 2 weeks on Days 1 and 15 (Cycles 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); oral pomalidomide 4 mg on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg oral or IV weekly on Days 1, 8, 15, and 22 (Cycle 1 onwards). Each cycle will consist of 28 days. Participants will continue to receive PVd or DPd until confirmed PD, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs earlier.
Participants will receive at least one cycle of bridging therapy (PVd or DPd) and additional cycles of bridging therapy may be considered based on participant's clinical status and timing of availability of cilta-cel along with conditioning regimen (cyclophosphamide 300 milligram \[mg\]/m\^2 intravenous \[IV\] and fludarabine 30 mg/m\^2 IV daily, for 3 days), and cilta-cel infusion 0.75 \* 10\^6 chimeric antigen receptor (CAR)-positive viable T cells/ kilogram (kg).
Interventions
Cilta-cel infusion will be administered at a target dose of 0.75 \* 10\^6 CAR-positive viable T cells/kilogram (kg).
Pomalidomide 4 mg will be administered orally.
Bortezomib 1.3 milligram per meter square (mg/m\^2) will be administered subcutaneously (SC).
Dexamethasone 20 mg/day (10mg/day for participants \>75 years of age) (on bortezomib treatment days and the days following bortezomib treatment) will be administered orally in PVd treatment; and orally or intravenous (IV) at 40 mg weekly (20mg weekly for participants \>75 years of age) in DPd treatment.
Daratumumab 1800 mg will be administered SC.