Trials / Active Not Recruiting
Active Not RecruitingNCT04181827
A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 419 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cilta-cel | Cilta-cel infusion will be administered at a target dose of 0.75 \* 10\^6 CAR-positive viable T cells/kilogram (kg). |
| DRUG | Pomalidomide | Pomalidomide 4 mg will be administered orally. |
| DRUG | Bortezomib | Bortezomib 1.3 milligram per meter square (mg/m\^2) will be administered subcutaneously (SC). |
| DRUG | Dexamethasone | 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. |
| DRUG | Daratumumab | Daratumumab 1800 mg will be administered SC. |
Timeline
- Start date
- 2020-06-12
- Primary completion
- 2024-05-01
- Completion
- 2029-04-09
- First posted
- 2019-12-02
- Last updated
- 2026-04-13
- Results posted
- 2025-05-20
Locations
88 sites across 16 countries: United States, Australia, Belgium, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Poland, South Korea, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04181827. Inclusion in this directory is not an endorsement.