Multiple MyelomaPhase 2CARTITUDE-2NCT04133636
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
A Phase 2 study testing JNJ-68284528, Lenalidomide and Daratumumab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 47 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- JNJ-68284528, Lenalidomide and Daratumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 47 sitesin 8 countries
- Study dates
- 7 Nov 2019to 25 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
47 sites in 8 countries.
47 sites in 8 countries
United States33 sites
Emory University
Atlanta, Georgia, 30322
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina, 28204
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana University
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Norton Cancer Institute
Louisville, Kentucky, 40207
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Yale University School Of Medicine
New Haven, Connecticut, 06510
Mount Sinai Medical Center
New York, New York, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
Oregon Health And Science University
Portland, Oregon, 97239
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23298
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84112
University Of California San Diego
San Diego, California, 92037
University of California San Francisco
San Francisco, California, 94143
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Washington University School Of Medicine
St Louis, Missouri, 63108
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Medical Center
The Bronx, New York, 10467
University of Kansas Cancer Center
Westwood, Kansas, 66205
France3 sites
CHRU de Lille Hopital Claude Huriez
Lille, 59037
C.H.U. Hotel Dieu - France
Nantes, 44093
Hopital Saint Louis
Paris, 75475
Germany2 sites
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246
Universitatsklinikum Wurzburg
Würzburg, 97080
Israel2 sites
Sheba Medical Center Tel Hashomer
Ramat Gan, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Netherlands2 sites
VU Medisch Centrum
Amsterdam, 1081 HV
University Medical Center Groningen
Groningen, 9713 GZ
Spain2 sites
Clinica Univ. de Navarra
Pamplona, 31008
Hosp Clinico Univ de Salamanca
Salamanca, 37007
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Center
Riyadh, 11211
About this study
Official title: 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
The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
- Conditions
- Multiple Myeloma
- Being tested
- JNJ-68284528, Lenalidomide, Daratumumab, Bortezomib, Dexamethasone
- Keywords
- Cellular Therapy, CAR-T Therapy, BCMA CAR-T
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-68284528Drug
Also called Ciltacabtagene autoleucel (cilta-cel)
Participants in Cohorts A,B,C, D, E, F and Cohort G (for US sites only) will receive JNJ-68284528 intravenously.
LenalidomideDrug
Some participants in Cohort D and all participants in Cohorts E and Cohort G (for US sites only) will also receive lenalidomide capsules orally.
DaratumumabDrug
Participants in Cohorts E and Cohort G (for US sites only) will also receive daratumumab subcutaneous (SC) injection.
BortezomibDrug
Participants in Cohorts E will also receive bortezomib subcutaneously.
DexamethasoneDrug
Participants in Cohorts E and Cohort G (for US sites only) will also receive dexamethasone orally or intravenously.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-68284528 | Experimental | Single group assignment-Post lymphodepletion, JNJ-68284528 single infusion given to Part A participants: Cohort A (Progressive disease post 1-3 prior lines of therapy), Cohort B (Early relapse post front-line), Cohort C(Relapsed/refractory multiple myeloma post PI, IMiD,anti-CD38,anti-BCMA therapy), Cohort D(Less than CR post ASCT front-line therapy, some participants will receive JNJ-68284528 then lenalidomide), Cohort F(Newly diagnosed multiple myeloma [NDMM], standard risk [International Staging System Stage I/II] and post initial therapy); Cohort E(NDMM,transplant not planned, high risk disease) will first receive quadruplet induction regimen of daratumumab, bortezomib, lenalidomide and dexamethasone(D-VRd) then lymphodepletion and JNJ-68284528 then consolidation regimen of lenalidomide. Enrollment is closed for Cohorts A,B,C,D,E and F. For US sites only: Part B:Cohort G (NDMM, transplant not planned) will receive daratumumab, lenalidomide and dexamethasone followed by cilta-cel. Receives: Drug: JNJ-68284528; Drug: Lenalidomide; Drug: Daratumumab; Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohorts A, B, C, D, E, and F: Percentage of Participants with Negative Minimal Residual Disease (MRD)
MRD negative rate is the percentage of participants who achieve MRD negative status by evaluation of bone marrow aspirate as defined by the International Myeloma Working Group (IMWG) criteria.
Measured: At least 1 year after JNJ-68284528 infusion on Day 1
For US sites only: Cohort G: Percentage of Participants with Sustained MRD Negative Complete Response (CR)
Sustained MRD-negative CR is defined as participants with CR or better who sustain MRD-negative status, as determined by next-generation sequencing (NGS) or next generation flowcytometry (NGF) with sensitivity of 10^-5, for at least 12 months without any examination showing MRD positive status or progressive disease in between.
Measured: At least 1 year after JNJ-68284528 infusion on Day 1
Secondary outcomes (24)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve a partial response (PR) or better according to the IMWG criteria.
Measured: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: VGPR or Better Rate
The VGPR or better rate (stringent complete responses [sCR] + complete response [CR] + VGPR), defined as the percentage of participants achieving VGPR or better response according to IMWG criteria during or after the study treatment.
Measured: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants who achieve ORR (sCR + CR + VGPR + PR) + minimal response (MR) according to the IMWG criteria.
Measured: Up to 8 years and 10 months
Duration of Response (DOR)
DOR will be calculated among responders from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria.
Measured: Up to 8 years and 10 months
Time to Response (TTR)
TTR is defined as the time from the date of the initial infusion of JNJ-68284528 and the first efficacy evaluation that the participant has met all criteria for PR or better.
Measured: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: MRD Negative Rate at 12 Months for Participants who Achieve a Complete Response (CR)
MRD negative rate at 12 months for participants who achieved a complete response (CR) is defined as the percentage of participants who are MRD negative by bone marrow aspirate and meet the IMWG criteria for CR at 12 months after initial dose of JNJ-68284528 and before disease progression or starting subsequent therapy including retreatment of JNJ-68284528.
Measured: 12 months
Time to MRD Negativity
Time to MRD negativity will be calculated in participants who are MRD negative by bone marrow aspirate from the date of the initial infusion of JNJ-68284528 to the initial date of reaching the MRD negative status.
Measured: Up to 8 years and 10 months
Duration of MRD Negativity
Duration of MRD negativity will be calculated among participants who are MRD negative by bone marrow aspirate from the date of initial MRD negativity to the date when MRD is detected at the same threshold (10^-5).
Measured: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: MRD Negative Rate Across Clinical Response
MRD negative rate across clinical response groups will be assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR) or very good partial response (VGPR) according to the IMWG criteria during or after the study treatment. MRD negative rate is defined as the percentage of participants who have negative MRD by bone marrow aspirate at any timepoint.
Measured: Up to 8 years and 10 months
Number of Participants with Adverse Events by Severity
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). CRS and ICANS will be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.
Measured: Up to 8 years and 10 months
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to 8 years and 10 months
Number of Participants with Laboratory Abnormalities
Number of participants with laboratory abnormalities will be reported.
Measured: Up to 8 years and 10 months
Number of Participants with Vital Signs Abnormalities
Number of participants with vital signs abnormalities will be reported.
Measured: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: Levels of B-Cell Maturation Antigen (BCMA) Expressing Cells and Soluble BCMA
Levels of expression of BCMA-expressing plasma cells in the bone marrow as well as the level of soluble BCMA in blood will be reported.
Measured: Up to 1 year
Cohorts A, B, C, D, E, and F: Systemic Inflammatory Cytokine Concentrations
Blood cytokine concentrations (Interleukin [IL]-6, IL-15, IL-10, and Interferon [IFN-gamma]) will be measured for biomarker assessment.
Measured: Up to 1 year
Cohorts A, B, C, D, E, and F: Levels of JNJ-68284528 T Cell Expansion (proliferation), and Persistence
Levels of JNJ-68284528 T cell expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.
Measured: Up to 1 year
Cohorts A, B, C, D, E, and F: Number of Participants with Anti-JNJ-68284528 Antibodies
Number of participants exhibiting anti-drug antibodies for JNJ-68284528 will be reported.
Measured: Up to 1 year
For US sites only: Cohort G: Percentage of Participants with Complete Response (CR) or Better
CR or better is defined as the percentage of participants achieving CR or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.
Measured: Up to 8 years and 10 months
For US sites only: Cohort G: Percentage of Participants with MRD-negative CR or sCR
MRD-negative CR/sCR is defined as the percentage of participants who achieve MRD-negative status, as determined by NGS/NGF with sensitivity of 10^-5, at any time after enrollment and prior to progressive disease or subsequent antimyeloma therapy and who achieve CR/sCR or better.
Measured: Up to 8 years and 10 months
For US sites only: Cohort G: Progression-free Survival on Next-line Therapy (PFS2)
PFS2 is defined as the time interval between the start of study treatment and date of event, which is defined as death from any cause or PD as assessed by investigator that starts after the next line of therapy, whichever occurs first.
Measured: Up to 8 years and 10 months
For US sites only: Cohort G: Overall Survival (OS)
OS is defined as the time from the start of study treatment to the date of the participant's death.
Measured: Up to 8 years and 10 months
For US sites only: Cohort G: Progression-free Survival (PFS)
PFS is defined as the time from the start of study treatment to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Measured: Up to 8 years and 10 months
For US sites only: Cohort G: Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Whole Blood
Number of participants with measurable RCL in whole blood will be reported.
Measured: Up to 8 years and 10 months
For US sites only: Cohort G: Time to Subsequent Anti-Myeloma Therapy
Time to subsequent anti-myeloma treatment is defined as the time from start of study treatment to the start of subsequent anti-myeloma treatment.
Measured: Up to 8 years and 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start7 Nov 2019
- Primary completion26 Feb 2027 (estimated)
- Study completion25 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133636
- Sponsor's protocol ID
- CR108581
- Other IDs
- 68284528MMY2003, 2018-004124-10, 2023-506587-13-00, 2023, 2018
- Acronym
- CARTITUDE-2
- Status last verified
- Nov 2026
- First submitted
- 18 Oct 2019
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
- Expanded access
- Available
Publications
Cohen AD, Mateos MV, Cohen YC, Rodriguez-Otero P, Paiva B, van de Donk NWCJ, Martin T, Suvannasankha A, De Braganca KC, Corsale C, Schecter JM, Varsos H, Deraedt W, Wang L, Vogel M, Roccia T, Xu X, Mistry P, Zudaire E, Akram M, Nesheiwat T, Pacaud L, Avivi I, San-Miguel J. Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to other BCMA-targeting agents. Blood. 2023 Jan 19;141(3):219-230. doi: 10.1182/blood.2022015526.
PubMed 36095849
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04133636
- Acronym / sponsor ID
- CARTITUDE-2 / CR108581
- Conditions
- Multiple Myeloma
- Keywords
- Cellular Therapy, CAR-T Therapy, BCMA CAR-T
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 25 Aug 2028 (estimated)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-68284528 | Experimental | Drug: JNJ-68284528, Drug: Lenalidomide, Drug: Daratumumab, Drug: Bortezomib, Drug: DexamethasoneSingle group assignment-Post lymphodepletion, JNJ-68284528 single infusion given to Part A participants: Cohort A (Progressive disease post 1-3 prior lines of therapy), Cohort B (Early relapse post front-line), Cohort C(Relapsed/refractory multiple myeloma post PI, IMiD,anti-CD38,anti-BCMA therapy), Cohort D(Less than CR post ASCT front-line therapy, some participants will receive JNJ-68284528 then lenalidomide), Cohort F(Newly diagnosed multiple myeloma [NDMM], standard risk [International Staging System Stage I/II] and post initial therapy); Cohort E(NDMM,transplant not planned, high risk disease) will first receive quadruplet induction regimen of daratumumab, bortezomib, lenalidomide and dexamethasone(D-VRd) then lymphodepletion and JNJ-68284528 then consolidation regimen of lenalidomide. Enrollment is closed for Cohorts A,B,C,D,E and F. For US sites only: Part B:Cohort G (NDMM, transplant not planned) will receive daratumumab, lenalidomide and dexamethasone followed by cilta-cel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-68284528Also: Ciltacabtagene autoleucel (cilta-cel)Participants in Cohorts A,B,C, D, E, F and Cohort G (for US sites only) will receive JNJ-68284528 intravenously. | Drug | JNJ-68284528 |
| LenalidomideSome participants in Cohort D and all participants in Cohorts E and Cohort G (for US sites only) will also receive lenalidomide capsules orally. | Drug | JNJ-68284528 |
| DaratumumabParticipants in Cohorts E and Cohort G (for US sites only) will also receive daratumumab subcutaneous (SC) injection. | Drug | JNJ-68284528 |
| BortezomibParticipants in Cohorts E will also receive bortezomib subcutaneously. | Drug | JNJ-68284528 |
| DexamethasoneParticipants in Cohorts E and Cohort G (for US sites only) will also receive dexamethasone orally or intravenously. | Drug | JNJ-68284528 |
Primary outcome
Cohorts A, B, C, D, E, and F: Percentage of Participants with Negative Minimal Residual Disease (MRD)
Time frame: At least 1 year after JNJ-68284528 infusion on Day 1
MRD negative rate is the percentage of participants who achieve MRD negative status by evaluation of bone marrow aspirate as defined by the International Myeloma Working Group (IMWG) criteria.
For US sites only: Cohort G: Percentage of Participants with Sustained MRD Negative Complete Response (CR)
Time frame: At least 1 year after JNJ-68284528 infusion on Day 1
Sustained MRD-negative CR is defined as participants with CR or better who sustain MRD-negative status, as determined by next-generation sequencing (NGS) or next generation flowcytometry (NGF) with sensitivity of 10^-5, for at least 12 months without any examination showing MRD positive status or progressive disease in between.
24 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: VGPR or Better Rate
Time frame: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: Clinical Benefit Rate (CBR)
Time frame: Up to 8 years and 10 months
Duration of Response (DOR)
Time frame: Up to 8 years and 10 months
Time to Response (TTR)
Time frame: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: MRD Negative Rate at 12 Months for Participants who Achieve a Complete Response (CR)
Time frame: 12 months
Time to MRD Negativity
Time frame: Up to 8 years and 10 months
Duration of MRD Negativity
Time frame: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: MRD Negative Rate Across Clinical Response
Time frame: Up to 8 years and 10 months
Number of Participants with Adverse Events by Severity
Time frame: Up to 8 years and 10 months
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
Time frame: Up to 8 years and 10 months
Number of Participants with Laboratory Abnormalities
Time frame: Up to 8 years and 10 months
Number of Participants with Vital Signs Abnormalities
Time frame: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: Levels of B-Cell Maturation Antigen (BCMA) Expressing Cells and Soluble BCMA
Time frame: Up to 1 year
Cohorts A, B, C, D, E, and F: Systemic Inflammatory Cytokine Concentrations
Time frame: Up to 1 year
Cohorts A, B, C, D, E, and F: Levels of JNJ-68284528 T Cell Expansion (proliferation), and Persistence
Time frame: Up to 1 year
Cohorts A, B, C, D, E, and F: Number of Participants with Anti-JNJ-68284528 Antibodies
Time frame: Up to 1 year
For US sites only: Cohort G: Percentage of Participants with Complete Response (CR) or Better
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Percentage of Participants with MRD-negative CR or sCR
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Progression-free Survival on Next-line Therapy (PFS2)
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Overall Survival (OS)
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Progression-free Survival (PFS)
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Whole Blood
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Time to Subsequent Anti-Myeloma Therapy
Time frame: Up to 8 years and 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 36095849Cohen AD, Mateos MV, Cohen YC, Rodriguez-Otero P, Paiva B, van de Donk NWCJ, Martin T, Suvannasankha A, De Braganca KC, Corsale C, Schecter JM, Varsos H, Deraedt W, Wang L, Vogel M, Roccia T, Xu X, Mistry P, Zudaire E, Akram M, Nesheiwat T, Pacaud L, Avivi I, San-Miguel J. Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to other BCMA-targeting agents. Blood. 2023 Jan 19;141(3):219-230. doi: 10.1182/blood.2022015526.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
47 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-68284528, Lenalidomide and Daratumumab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 47 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, France, Belgium, Germany, Israel and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohorts A, B, C, D, E, and F: Percentage of Participants with Negative Minimal Residual Disease (MRD) (time frame: At least 1 year after JNJ-68284528 infusion on Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04133636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.