Multiple Myeloma Clinical Trial
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
Summary
The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
Full Description
Multiple myeloma is a malignant plasma cell disorder diagnosed annually in approximately 86,000 participants worldwide. JNJ-68284528 (cilta-cel) is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. The primary hypothesis for this study is that JNJ-68284528 (cilta-cel) will significantly improve progression free survival (PFS) compared with standard therapy (PVd or DPd), in participants who have previously received 1 to 3 prior line(s) of therapy, that included a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) and who are refractory to lenalidomide. This study will be conducted in 3 phases: Screening (up to 28 days before randomization), Treatment, and Follow-Up. Assessment like patient-reported outcome(s) (PROs) assessments, electrocardiogram (ECG), vital signs, pharmacokinetic will be performed during the study. Safety evaluations will include review of adverse events, laboratory test results, vital sign measurements, physical examination findings, and assessments of cardiac function, Immune Effector Cell-associated Encephalopathy (only for Arm B) and Eastern Cooperative Oncology Group performance status. Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). The duration of the study is approximately 6 years.
Eligibility Criteria
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):
Hemoglobin >=8 gram per deciliter (g/dL) (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted);
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);
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;
Lymphocyte count >=0.3 * 10^9/L;
Aspartate aminotransferase (AST) less than or equal to (<=)3 * upper limit of normal (ULN);
Alanine aminotransferase (ALT) <=3 * ULN;
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);
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
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There are 87 Locations for this study
Birmingham Alabama, 35294, United States
Phoenix Arizona, 85054, United States
Stanford California, 94305, United States
Denver Colorado, 80218, United States
New Haven Connecticut, 06520, United States
Miami Florida, 33136, United States
Iowa City Iowa, 52242, United States
Westwood Kansas, 66205, United States
Baltimore Maryland, 21201, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Durham North Carolina, 27710, United States
Columbus Ohio, 43210, United States
Salt Lake City Utah, 84112, United States
Madison Wisconsin, 53705, United States
Milwaukee Wisconsin, 53226, United States
Adelaide , 5000, Australia
Camperdown , 2050, Australia
Herston , 4029, Australia
Melbourne , 3000, Australia
Melbourne , 3004, Australia
Murdoch , 6150, Australia
Antwerp , 2650, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Liege , B-400, Belgium
Copenhagen , 2100, Denmark
LILLE Cedex , 59037, France
Montpellier , 34295, France
Nantes , 44093, France
Paris cedex 10 , 75475, France
Pierre Benite cedex , 69495, France
Poitiers , 86021, France
Toulouse cedex 9 , 31059, France
Dresden , 01307, Germany
Hamburg , 20246, Germany
Köln , 50924, Germany
Leipzig , 04103, Germany
Tübingen , 72076, Germany
Würzburg , 97080, Germany
Athens , 12462, Greece
Jerusalem , P.O.B, Israel
Ramat Gan , 74047, Israel
Tel-Aviv , 64239, Israel
Bologna , 40138, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Roma , 00168, Italy
Turin , 10126, Italy
Fukuoka , 812-8, Japan
Kanazawa , 920-8, Japan
Kyoto , 602-8, Japan
Nagoya , 467-8, Japan
Okayama , 700-8, Japan
Sapporo , 060-8, Japan
Sendai , 980-8, Japan
Shibuya , 150-8, Japan
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Amsterdam , 1081 , Netherlands
Groningen , 9713 , Netherlands
Rotterdam , 3015 , Netherlands
Utrecht , 3584 , Netherlands
Gdansk , 80-21, Poland
Gliwice , 44102, Poland
Poznan , 60-56, Poland
Warszawa , 02-77, Poland
Badalona , 08916, Spain
Barcelona , 08036, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Lund , 221 8, Sweden
Stockholm , 141 8, Sweden
Uppsala , 751 8, Sweden
Birmingham , B15 2, United Kingdom
Bristol , BS2 8, United Kingdom
Cardiff , CF14 , United Kingdom
London , NW1 2, United Kingdom
London , SE5 9, United Kingdom
Manchester , M20 4, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
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