Multiple MyelomaPhase 1NCT06768489
A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma
A Phase 1 study testing JNJ-79635322, Daratumumab and Pomalidomide in people with Multiple Myeloma and Smoldering Multiple Myeloma, run by Janssen Research & Development, LLC at 16 sites in 5 countries.
Trial summary
The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses [RP2Ds]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Smoldering Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis
- What is being tested?
- JNJ-79635322, Daratumumab and Pomalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 4 Dec 2024to 29 Jun 2029
- Phase
- Phase 1
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
None listed.
Who cannot join
- Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: a) Targeted therapy, epigenetic therapy, monoclonal antibody (mAb) treatment, or treatment with an investigational drug or an invasive investigational medical device within 21 days or 5 half-lives, whichever is less. b) Gene-modified adoptive cell therapy (example, chimeric antigen receptor [CAR] modified T cells, natural killer cells) within 90 days. c) Prior anti-CD38 directed therapy within 90 days (for treatment regimens A, C, D and E only; within 21 days for treatment regimen B). d) Conventional chemotherapy within 21 days. e) PI therapy within 14 days. f) Immunomodulatory agent therapy within 7 days. g) Radiotherapy within 14 days
- Stem cell transplantation: a) Allogeneic stem cell transplant within 6 months before the first dose of study treatment. b) Received an autologous stem cell transplant <=12 weeks before the first dose of study treatment
- Nonhematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to grade <=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy grade <=3)
- Prior treatment with CD3-redirecting therapy
- Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, >=60 percent (%) plasma cells in the bone marrow, or hypercalcemia
- Macroglossia that impairs swallowing difficulty
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- Prior therapy for AL amyloidosis or multiple myeloma
- Multiple myeloma, requiring treatment
- Primary systemic AL (immunoglobulin light chain) amyloidosis
- Any serious underlying medical conditions, such as: Evidence of active viral, bacterial, or systemic fungal infection requiring ongoing antiviral, antibacterial, or antifungal treatment; active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment; cardiovascular dysfunction; pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation; human immunodeficiency (HIV) infection; active hepatitis B or C infection; stroke or seizure within 6 months prior to first dose of study treatment
- Known or suspected chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (<) 50 percent (%)
Trial locations and contacts
16 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 5 countries
Australia5 sites, 5 recruiting
- Recruiting
Monash Medical Centre
Clayton, 3168
- Recruiting
St Vincents Hospital Melbourne
Fitzroy, 3065
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, 3000
- Recruiting
Calvary Mater Newcastle Hospital
Waratah, 2298
- Recruiting
Wollongong Hospital
Wollongong, 2500
Israel4 sites, 4 recruiting
- Recruiting
Carmel Medical Center
Haifa, 3436212
- Recruiting
Hadassah Medical Center
Jerusalem, 9112001
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Netherlands3 sites, 3 recruiting
- Recruiting
VU Medisch Centrum
Amsterdam, 1081 HV
- Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
- Recruiting
UMC Utrecht
Utrecht, 3584 CX
United States2 sites, 2 recruiting
- Recruiting
Winship Cancer Institute Emory University
Atlanta, Georgia, 30322
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Spain2 sites, 2 recruiting
- Recruiting
Hosp. Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hosp Clinico Univ de Salamanca
Salamanca, 37007
About this study
Official title: A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or in Combination With Pomalidomide for Multiple Myeloma
The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses [RP2Ds]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).
- Being tested
- JNJ-79635322, Daratumumab, Pomalidomide, Lenalidomide
- Medical subject headings
- Multiple Myeloma, Smoldering Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-79635322Drug
JNJ-79635322 will be administered subcutaneously.
DaratumumabDrug
Daratumumab will be administered subcutaneously.
PomalidomideDrug
Pomalidomide will be administered orally.
LenalidomideDrug
Lenalidomide will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Regimen A and C: JNJ-79635322+Daratumumab | Experimental | Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) (Treatment regimen A1 and A3) will receive JNJ-79635322 along with daratumumab to establish the recommended phase 2 doses (RP2D[s]) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Based on the study evaluation team (SET) decision, enrollment may proceed in participants with newly diagnosed multiple myeloma (NDMM) (Treatment regimens A2, A4 and C). Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. Receives: Drug: JNJ-79635322; Drug: Daratumumab |
| Treatment Regimen B: JNJ-79635322+Pomalidomide | Experimental | Participants who have received greater than or equal to (>=)1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory or >=2 prior lines of therapy, including a PI and lenalidomide will receive JNJ-79635322 along with pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. Receives: Drug: JNJ-79635322; Drug: Pomalidomide |
| Treatment Regimen D and E: JNJ-79635322 + Daratumumab + Lenalidomide Combination | Experimental | Participants with NDMM will receive JNJ-79635322 along with daratumumab and lenalidomide to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. Receives: Drug: JNJ-79635322; Drug: Daratumumab; Drug: Lenalidomide |
| Treatment Regimen F: JNJ-79635322 + Daratumumab | Experimental | Participants with newly diagnosed amyloid light chain (ND AL) amyloidosis will receive JNJ-79635322 in treatment regimen F along with daratumumab to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. Receives: Drug: JNJ-79635322; Drug: Daratumumab |
| Treatment Regimen G: JNJ-79635322 + Daratumumab | Experimental | Participants with high-risk smoldering multiple myeloma (SMM) will receive JNJ-79635322 in treatment regimen G along with daratumumab to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. Receives: Drug: JNJ-79635322; Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Measured: Up to 28 days
Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Measured: Up to 3 Years and 3 months
Number of Participants with Clinically Significant Laboratory Abnormalities
Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported.
Measured: Up to 3 Years and 3 months
Secondary outcomes (19)
Percentage of Participants With Overall Response Rate
Overall response rate is defined as percentage of participants with newly diagnosed multiple myeloma (NDMM), relapsed or refractory multiple myeloma (R/R MM), or high-risk smoldering multiple myeloma (SMM) who have a partial response (PR) or better evaluated by the investigator as per international myeloma working group (IMWG) 2016 criteria.
Measured: Up to 3 Years and 3 months
Percentage of Participants With Very Good Partial Response (VGPR) or Better Response Rate
VGPR or better response rate is defined as the percentage of participants with NDMM, R/R MM, or high-risk SMM who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria.
Measured: Up to 3 Years and 3 months
Percentage of Participants With CR or Better Response Rate
CR or better response rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
Measured: Up to 3 Years and 3 months
Percentage of Participants With sCR or Better Response Rate
sCR rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve an sCR according to the IMWG 2016 criteria.
Measured: Up to 3 Years and 3 months
Duration of Response (DOR)
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), as per IMWG 2016 response criteria, or death due to progression, whichever occurs first in participants with NDMM, R/R MM, or high-risk SMM.
Measured: Up to 3 Years and 3 months
Time to Response (TTR)
TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participants with NDMM, R/R MM, or high-risk SMM has met all criteria for PR or better as defined by IMWG 2016 response criteria.
Measured: Up to 3 Years and 3 months
Percentage of Participants With Hematologic Response As Defined by International Amyloidosis Consensus Criteria
Hematologic response is defined as percentage of participants with newly diagnosed amyloid light chain (ND AL) amyloidosis who achieve complete response, very good partial response, partial response, no response and progression as defined by International amyloidosis consensus criteria present in the protocol will be reported.
Measured: Up to 3 Years and 3 months
DOR as Defined by International Amyloidosis Consensus Criteria
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), as per International amyloidosis consensus criteria, or death due to progression, whichever occurs first in participants with ND AL amyloidosis.
Measured: Up to 3 Years and 3 months
TTR as Defined by International Amyloidosis Consensus Criteria
TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant with ND AL amyloidosis has met all criteria for PR or better as defined by International amyloidosis consensus criteria.
Measured: Up to 3 Years and 3 months
Serum Concentration of JNJ-79635322 and Daratumumab
Serum samples will be analyzed to determine concentrations of JNJ-79635322 and daratumumab.
Measured: Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUCinf) for JNJ-79635322 and Daratumumab
AUCinf for JNJ-79635322 and daratumumab will be reported.
Measured: Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve from Time Zero to the Last Measurable Concentration [AUC(0-t)] for JNJ-79635322 and Daratumumab
AUC(0-t) for JNJ-79635322 and daratumumab will be reported.
Measured: Up to 3 Years and 3 months
Area Under the Serum Concentration Time Curve During the Dosing Interval (AUCtau) for JNJ-79635322 and Daratumumab
AUCtau for JNJ-79635322 and daratumumab will be reported.
Measured: Up to 3 Years and 3 months
Maximum Serum Concentration (Cmax) for JNJ-79635322 and Daratumumab
Cmax for JNJ-79635322 and daratumumab will be reported.
Measured: Up to 3 Years and 3 months
Half Life (T1/2) for JNJ-79635322 and Daratumumab
T1/2 for JNJ-79635322 and daratumumab will be reported.
Measured: Up to 3 Years and 3 months
Time to Reach Cmax (Tmax) for JNJ-79635322 and Daratumumab
Tmax for JNJ-79635322 and daratumumab will be reported.
Measured: Up to 3 Years and 3 months
Systemic Clearance (CL/F) for JNJ-79635322 and Daratumumab
CL/F for JNJ-79635322 and daratumumab will be reported.
Measured: Up to 3 Years and 3 months
Apparent Volume of Distribution at Steady State (Vss/F) for JNJ-79635322 and Daratumumab
Vss/F for JNJ-79635322 and daratumumab will be reported.
Measured: Up to 3 Years and 3 months
Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 and Daratumumab
Participants with anti-drug antibodies to JNJ-79635322 and daratumumab will be reported.
Measured: Up to 3 Years and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start4 Dec 2024
- Primary completion2 Jan 2029 (estimated)
- Study completion29 Jun 2029 (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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
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
- NCT06768489
- Sponsor's protocol ID
- 79635322MMY1002
- Other IDs
- 2024-515316-44-00
- Status last verified
- Sep 2026
- First submitted
- 23 Dec 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at 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
Publications
Pillarisetti K, Yang D, Luistro L, Yao J, Smith M, Vulfson P, Testa JS, Ponticiello R, Brodeur S, Heidrich B, Packman K, Singh S, Attar R, Elsayed Y, Philippar U. Ramantamig (JNJ-79635322), a novel T-cell-engaging trispecific antibody targeting BCMA, GPRC5D, and CD3, in multiple myeloma models. Blood. 2026 Feb 19;147(8):834-847. doi: 10.1182/blood.2025030027.
PubMed 41100731