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 CARTITUDE-2
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What's the purpose of this trial?

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

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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
  • 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
  • Cohort H: Considered a candidate for high-dose chemotherapy with ASCT as initial treatment
  • Cohorts A, B, C, E, G, H:
  • 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, G, H: 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
  • Cohorts F, G, and H: 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
  • Cohorts E, G, and H: Frailty index of >= 2 according to Myeloma Geriatric Assessment score

Additional Trial Information

Phase 2

Enrollment: 80 patients (estimated)

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Trial Links

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Moores Cancer Center University of California UC San Diego Health

La Jolla, CA

Not Yet Accepting

Stanford University Cancer Institute (Palo Alto)

Stanford, CA

Not Yet Accepting

Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Not Yet Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Recruitment on Hold

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Recruitment on Hold

Northside Hospital (Atlanta)

Atlanta, GA

Not Yet Accepting

Illinois

Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine

Chicago, IL

Recruitment on Hold

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Recruitment on Hold

Indiana

Simon Cancer Center Indiana University

Indianapolis, IN

Recruitment on Hold

Iowa

Holden Comprehensive Cancer Center - University of Iowa University of Iowa Hospitals and Clinics

Iowa City, IA

Open and Accepting

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Recruitment on Hold

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Recruitment on Hold

New Jersey

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Recruitment on Hold

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Recruitment on Hold

Montefiore Medical Center

Bronx, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

North Carolina

Atrium Health's Levine Cancer Institute - Charlotte (Main) Atrium Health

Charlotte, NC

Open and Accepting

Ohio

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Not Yet Accepting

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Not Yet Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Not Yet Accepting

Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, PA

Open and Accepting

Abramson Cancer Center - University of Pennsylvania (UPENN) University of Pennsylvania

Philadelphia, PA

Open and Accepting

UPMC Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Open and Accepting

Texas

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Not Yet Accepting

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Not Yet Accepting

Washington

Fred Hutchinson Cancer Research Center University of Washington Cancer Consortium / SCCA

Seattle, WA

Recruitment on Hold
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