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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
Not Recruiting
Trial ID: NCT04181827
Purpose
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).
Official Title
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
Stanford Investigator(s)
Surbhi Sidana, MD
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
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
Intervention(s):
drug: JNJ-68284528
drug: Pomalidomide
drug: Bortezomib
drug: Dexamethasone
drug: Daratumumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Emma Crawford
650-736-1442