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NCT04133636Active, not recruitingPhase 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

68284528MMY2003: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
208 (actual)
First submitted
18 Oct 2019
Start date
7 Nov 2019
Primary completion date
26 Feb 2027
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04133636
EU CT number
2023-506587-13-00
EudraCT number
2018-004124-10

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 208
  • From 7 Nov 2019 to the primary completion date, 26 Feb 2027
  • 47 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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
  • 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

Other illness

  • 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

Other

  • Cohorts A, B, C, D, F:
  • Cohort E and Cohort G (for US sites only): Frailty index of \>= 2 according to Myeloma Geriatric Assessment score

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Sheba Medical Center, Tel Hashomer
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Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Amsterdam UMC
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AmsterdamNetherlandsActive, not recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
King Faisal Specialist Hospital & Research Center
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RiyadhSaudi ArabiaUnknown status
Emory University
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AtlantaUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
Levine Cancer Institute, Carolinas HealthCare System
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CharlotteUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
Barbara Ann Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
University of Iowa Hospitals and Clinics
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Iowa CityUnited StatesUnknown status
Norton Cancer Institute
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LouisvilleUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center
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MadisonUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
Mount SInai Medical Center
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
University of Pittsburgh
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PittsburghUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Virginia Commonwealth University/Massey Cancer Center
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RichmondUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
University of California San Diego
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San DiegoUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Fred Hutchinson Cancer Center
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SeattleUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
University of Kansas Cancer Center
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WestwoodUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.