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Active (not recruiting) Phase 3 NCT04181827

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

Phase 3 – large-scale trial before approval
Conditions: Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
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).
Who can participate
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
Locations 15
Australia (1)
Royal Adelaide Hospital
Adelaide
Belgium (1)
Universitair Ziekenhuis - Antwerpen
Antwerp
Denmark (1)
Rigshospitalet
Copenhagen
France (1)
CHRU de Lille Hopital Claude Huriez
Lille
Greece (1)
Attikon University General Hospital of Attica
Athens
Israel (1)
Hadassah University Hospita Ein Kerem
Jerusalem
Italy (1)
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
Bologna
Japan (1)
Kyushu University Hospital
Fukuoka
Netherlands (1)
VU Medisch Centrum
Amsterdam
Poland (1)
Uniwersyteckie Centrum Kliniczne
Gdansk
South Korea (1)
Seoul National University Hospital
Seoul
Spain (1)
Inst. Cat. D'Oncologia-Badalona
Badalona
Sweden (1)
Skane University Hospital
Lund
United Kingdom (1)
Queen Elizabeth Hospital
Birmingham
United States (1)
University of Alabama at Birmingham
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.06.2020
Completion date
09.04.2029
Registry ID
NCT04181827
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.