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
Condition(s) studied
Investigational drug(s) / intervention(s)
Cilta-cel: Cilta-cel infusion will be administered at a target dose of 0.75 \* 10\^6 CAR-positive viable T cells/kilogram (kg).
Pomalidomide: Pomalidomide 4 mg will be administered orally.
Bortezomib: Bortezomib 1.3 milligram per meter square (mg/m\^2) will be administered subcutaneously (SC).
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.
Daratumumab: Daratumumab 1800 mg will be administered SC.
Study 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).
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years)
PFS: defined as time from date of randomization to date of first documented progressed disease (PD) as per International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams per deciliter \[g/dL\] and \>=200 milligrams \[mg\] per 24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase of \>10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC)% (absolute increase of \>=10%), appearance of new lesion; definite development of new bone lesions or definite increase in size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per microliter \[uL\]) if this was only measure of disease.
Trial sites (88)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Mayo Clinic Cancer Center-Scottsdale | Phoenix | Arizona | |
| Stanford University Medical Center | Stanford | California | |
| Colorado Blood Cancer Institute | Denver | Colorado | |
| Yale New Haven Hospital | New Haven | Connecticut | |
| University Of Miami Leonard M Mille School Of Medicine SCCC | Miami | Florida | |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | |
| University of Kansas | Westwood | Kansas | |
| University Of Maryland Medical Center | Baltimore | Maryland | |
| Mayo Clinic - Rochester | Rochester | Minnesota | |
| Washington University School Of Medicine | St Louis | Missouri | |
| Hackensack University Medical Center | Hackensack | New Jersey | |
| Memorial Sloan-Kettering Cancer Center | New York | New York | |
| University of Rochester Medical Center | Rochester | New York | |
| Duke University Medical Center | Durham | North Carolina | |
| The Ohio State University | Columbus | Ohio | |
| Huntsman Cancer Institute | Salt Lake City | Utah | |
| Wisconsin Institutes for Medical Research | Madison | Wisconsin | |
| Medical College Of Wisconsin | Milwaukee | Wisconsin | |
| Royal Adelaide Hospital | Adelaide | Australia | |
| Royal Prince Alfred Hospital | Camperdown | Australia | |
| Royal Brisbane and Womens Hospital | Herston | Australia | |
| Peter MacCallum Cancer Centre | Melbourne | Australia | |
| Alfred Health | Melbourne | Australia | |
| Fiona Stanley Hospital | Murdoch | Australia | |
| Universitair Ziekenhuis - Antwerpen | Antwerp | Belgium | |
| UZ Gent | Ghent | Belgium | |
| UZ Leuven | Leuven | Belgium | |
| Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman | Liège | Belgium | |
| Rigshospitalet | Copenhagen | Denmark | |
| CHRU de Lille Hopital Claude Huriez | Lille | France | |
| Hospices Civils de Lyon HCL | Lyon | France | |
| CHU de Montpellier Hopital Saint Eloi | Montpellier | France | |
| C.H.U. Hotel Dieu - France | Nantes | France | |
| Hopital Saint Louis | Paris | France | |
| CHU De Poitiers | Poitiers | France | |
| Institut Universitaire du cancer de Toulouse-Oncopole | Toulouse | France | |
| Universitaetsklinikum Koeln | Cologne | Germany | |
| Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden | Dresden | Germany | |
| Universitaetsklinikum Hamburg Eppendorf | Hamburg | Germany |
+ 48 more sites — see the full list on the official registry below.
On this site
📄 Darzalex (daratumumab) drug profile →More Janssen Research & Development, LLC trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04181827 on ClinicalTrials.gov ↗ ← All trials in the UK