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Clinical Trials in the USA / NCT04133636
Active, not recruiting Phase 2

A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma

NCT04133636 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2
Started
2019-11-07
Last updated
2026-08-31

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

JNJ-68284528Lenalidomide →Daratumumab →Bortezomib →Dexamethasone →

JNJ-68284528: Participants in Cohorts A,B,C, D, E, F and Cohort G (for US sites only) will receive JNJ-68284528 intravenously.

Lenalidomide: Some participants in Cohort D and all participants in Cohorts E and Cohort G (for US sites only) will also receive lenalidomide capsules orally.

Daratumumab: Participants in Cohorts E and Cohort G (for US sites only) will also receive daratumumab subcutaneous (SC) injection.

Bortezomib: Participants in Cohorts E will also receive bortezomib subcutaneously.

Dexamethasone: Participants in Cohorts E and Cohort G (for US sites only) will also receive dexamethasone orally or intravenously.

Study summary

The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines * Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than or equal to (\<=) 12 months after treatment with autologous stem cell transplantation (ASCT) or \<=12 months from the start of anti-myeloma therapy for participants who have not had an ASCT * Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy * Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation * Cohort E: Have newly diagnosed multiple myeloma without prior therapy (one cycle of prior therapy before enrollment is acceptable) and classified as high risk defined as either: 1) International Staging System (ISS) stage III criteria, Beta 2 microglobulin greater than or equal to (\>=) 5.5 milligrams per liter (mg/L) (via local or central laboratory assessment) or 2) high risk cytogenetic features del(17/17p), t (14;16), t(14;20), 1q amplification (at least 4 total copies) in at least 20 percent (%) of the total plasma cell population * Cohort F: * Participant must have a documented efficacy response of very good partial response (VGPR) or better, without progressive disease prior to enrollment, as assessed per IMWG 2016 criteria * Received initial therapy as specified below. The dose/schedule of cycles administered will be as per standard of care. It is acceptable for up to 1 cycle of the protocol-specified regimens to be missing one of the listed agents (example, held due to toxicity). Acceptable combinations include: At least 5 to 8 cycles of initial therapy with daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd). The dose/schedule of cycles administered will be as per standard of care or; at least 4 to 8 cycles of initial therapy with daratumumab, lenalidomide and dexamethasone (D-Rd) or; at least 4 to 8 cycles of initial therapy with a carfilzomib-based triplet or quadruplet regimen * For US sites only: Cohort G: Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: a) Ineligibility due to advanced age; or b) Ineligibility due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or c) Subject refusal of high-dose chemotherapy with ASCT as initial treatment * Cohorts A, B, C, E and Cohort G (for US sites only): * Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) or urine M-protein level \>=200 milligrams (mg)/24 hours * Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio * Cohort A: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole -body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria. A minimum of one lesion with a bi-dimensional measurement of at least 1 centimeter (cm)\*1 cm is required * Cohorts B, C: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria * Cohorts A, B, C, D, E, F and Cohort G (for US sites only): Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 Exclusion Criteria: * Cohorts A, B, D, F: Any therapy that is targeted to BCMA * Cohorts A, B, C, D, F: Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target * Cohorts A, B, C, D, F: * Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy * Received a cumulative dose of corticosteroids equivalent to \>=70 mg of prednisone within the 7 days (Cohort A, B, C, F) or 14 days (Cohort D) prior to apheresis * Serious underlying medical condition, such as (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) any history of Parkinson's disease or other neurodegenerative disorder * Cohorts A, B, C, D, E, F: Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma * Cohort F and Cohort G (for US sites only): Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: a) non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured; b) skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured; c) non-invasive cervical cancer treated within the last 24 months that is considered completely cured; d) localized prostate cancer (N0M0): with a Gleason score of greater than or equal to (=\>)6, treated within the last 24 months or untreated and under surveillance, with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence, or history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence, e) breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence; f) malignancy that is considered cured with minimal risk of recurrence * Cohort E and Cohort G (for US sites only): Frailty index of \>= 2 according to Myeloma Geriatric Assessment score

Primary outcome measure(s)

Trial sites (47)

FacilityCityRegionStatus
University Of California San Diego San Diego California
University of California San Francisco San Francisco California
Yale University School Of Medicine New Haven Connecticut
Moffitt Cancer Center Tampa Florida
Emory University Atlanta Georgia
Northwestern University Chicago Illinois
University of Chicago Chicago Illinois
Indiana University Indianapolis Indiana
University of Iowa Hospitals and Clinics Iowa City Iowa
University of Kansas Cancer Center Westwood Kansas
Norton Cancer Institute Louisville Kentucky
Dana Farber Cancer Institute Boston Massachusetts
Barbara Ann Karmanos Cancer Institute Detroit Michigan
Mayo Clinic Rochester Rochester Minnesota
Washington University School Of Medicine St Louis Missouri
Hackensack University Medical Center Hackensack New Jersey
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
Roswell Park Cancer Institute Buffalo New York
Mount Sinai Medical Center New York New York
Memorial Sloan-Kettering Cancer Center New York New York
Montefiore Medical Center The Bronx New York
Levine Cancer Institute, Carolinas HealthCare System Charlotte North Carolina
Cleveland Clinic Cleveland Ohio
Oregon Health And Science University Portland Oregon
University of Pennsylvania Philadelphia Pennsylvania
Thomas Jefferson University Philadelphia Pennsylvania
University of Pittsburgh Pittsburgh Pennsylvania
University of Texas Southwestern Medical Center Dallas Texas
University of Utah Salt Lake City Utah
University of Virginia Charlottesville Virginia
Virginia Commonwealth University - Massey Cancer Center Richmond Virginia
Fred Hutchinson Cancer Center Seattle Washington
University of Wisconsin Carbone Cancer Center Madison Wisconsin
UZ Gent Ghent Belgium
UZ Leuven Leuven Belgium
CHRU de Lille Hopital Claude Huriez Lille France
C.H.U. Hotel Dieu - France Nantes France
Hopital Saint Louis Paris France
Universitaetsklinikum Hamburg Eppendorf Hamburg Germany
Universitatsklinikum Wurzburg Würzburg Germany

+ 7 more sites — see the full list on the official registry below.

On this site

📄 Revlimid (lenalidomide) drug profile → 📄 Darzalex (daratumumab) drug profile →

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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 NCT04133636 on ClinicalTrials.gov ↗ ← All trials in the USA