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Clinical Trials in the UK / NCT04181827
Active, not recruiting Phase 3

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

NCT04181827 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2020-06-12
Last updated
2026-08-31

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Cilta-celPomalidomideBortezomibDexamethasoneDaratumumab

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Measurable disease at screening as defined by any of the following: (a) Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL) or urine M-protein level \>=200 milligram (mg)/24 hours; or (b) Light chain multiple myeloma without measurable M-protein in the serum or the urine: Serum free light chain \>=10 mg/dL and abnormal serum free light chain ratio * Have received 1 to 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) * Have documented evidence of PD by International Myeloma Working Group (IMWG) criteria based on investigator's determination on or within 6 months of their last regimen * Be refractory to lenalidomide per IMWG consensus guidelines (failure to achieve minimal response or progression on or within 60 days of completing lenalidomide therapy). Progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion. For participants with more than 1 prior line of therapy, there is no requirement to be lenalidomide refractory to the most recent line of prior therapy. However, participants must be refractory to lenalidomide in at least one prior line * Have clinical laboratory values meeting the following criteria during the Screening Phase (re testing is allowed but the below criteria must be met in the latest test prior to randomization): 1. Hemoglobin \>=8 gram per deciliter (g/dL) (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted); 2. Absolute neutrophil count (ANC) \>=1 \* 10\^9 per liter (L) (without recombinant human granulocyte colony-stimulating factor \[G-CSF\] within 7 days and without pegylated G-CSF within 14 days of the laboratory test); 3. Platelet count \>=75 \* 10\^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom less than (\<) 50 percent (%) of bone marrow nucleated cells are plasma cells; platelet count \>=50 \* 10\^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom \>=50% of bone marrow nucleated cells are plasma cells; 4. Lymphocyte count \>=0.3 \* 10\^9/L; 5. Aspartate aminotransferase (AST) less than or equal to (\<=)3 \* upper limit of normal (ULN); 6. Alanine aminotransferase (ALT) \<=3 \* ULN; 7. Total bilirubin \<=2.0 \* ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin \<=1.5 \* ULN is required); 8. Estimated glomerular filtration rate \>=40 milliliter per minute (mL/min) per 1.73 meter square (m\^2) (to be calculated using the Modification of Diet in Renal Disease \[MDRD\] formula) Exclusion Criteria: * Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy directed at any target * Any previous therapy that is targeted to B-cell maturation antigen (BCMA) * Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia * Participants with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy will not be permitted to receive pomalidomide, bortezomib, and dexamethasone (PVd) as standard therapy or bridging therapy; however, participants may receive daratumumab, pomalidomide, and dexamethasone (DPd) as standard therapy or bridging therapy * Received a cumulative dose of corticosteroids equivalent to \>=70 mg of prednisone within the 7 days prior to randomization * Monoclonal antibody treatment within 21 days * Cytotoxic therapy within 14 days * Proteasome inhibitor therapy within 14 days * Immunomodulatory drug (IMiD) therapy within 7 days

Primary outcome measure(s)

Trial sites (88)

FacilityCityRegionStatus
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.

Official registry record

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