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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

Trial Status: Active

The purpose of this study is to compare the efficacy of JNJ-68284528 with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).

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 (>=) 1.0 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
  • 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 subjects 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 subjects 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 subjects 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, participant 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

Connecticut

New Haven
Yale University
Status: IN_REVIEW

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: IN_REVIEW

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: IN_REVIEW

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Multiple myeloma is a malignant plasma cell disorder diagnosed annually in approximately

86,000 participants worldwide. JNJ-68284528 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 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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Janssen Pharmaceuticals

  • Primary ID CR108695
  • Secondary IDs NCI-2020-05552, 2019-001413-16, 68284528MMY3002
  • Clinicaltrials.gov ID NCT04181827