Combining JNJ-79635322 with Daratumumab or Pomalidomide for Multiple Myeloma Treatment
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
Run by Janssen Research & Development, LLC · NCT06768489 · Data updated 2026-11-12
This study is testing a new drug called JNJ-79635322 combined with either daratumumab or pomalidomide to see how safe and effective it is for people with multiple myeloma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 276 (estimated) |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | daratumumab, chimeric antigen receptor, chemotherapy |
| Locations | 16 sites (Denver, Colorado and 15 other locations) |
| Status | Recruiting |
| Started | December 4, 2024 |
| Main results expected | January 2, 2029 |
| Study ends | June 29, 2029 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT06768489 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with documented multiple myeloma who have received prior therapies or are newly diagnosed and treatment-naïve.
✕Probably not a fit
Patients who have not been diagnosed with multiple myeloma or those who have not met the specific treatment history requirements may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to determine the safe and effective doses of JNJ-79635322 when used in combination with either daratumumab or pomalidomide for patients with multiple myeloma. The trial is divided into two parts: the first part focuses on dose escalation to identify recommended doses, while the second part expands on the safety and tolerability of these combinations at the selected doses. Participants will be monitored for their response to the treatment and any potential side effects.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with multiple myeloma who have limited treatment choices.
How similar studies have gone: Other studies have shown promising results with similar combination therapies in multiple myeloma, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria for newly diagnosed multiple myeloma (NDMM) and relapsed or refractory multiple myeloma (R/R MM): * Have documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria * Meet treatment regimen-specific requirements as follows: Treatment regimen A (JNJ-79635322+daratumumab):Treatment regimens A1 and A3: Have been treated with 1 to 3 prior lines of therapy, including a proteasome inhibitor (PI) and an inhibitor, immunomodulatory drug (IMiD) therapy for the treatment of multiple myeloma (MM); Treatment regimens A2 and A4: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments; Treatment regimen B (JNJ-79635322+pomalidomide): 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; Treatment Regimens C, D, and E: Newly diagnosed MM naïve to multiple myeloma (or other related plasma cell neoplasm)-directed treatments * Have a weight \>=40 kilograms * Must have an Eastern Cooperative Oncology Group status of 0 or 2 * Have measurable disease at screening as defined by at least 1 of the following: a) Serum monoclonal protein (M-protein) level \>= 0.5 gram per deciliter (g/dL); or b) Urine M-protein level \>=200 milligram (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>= 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio. d) For participants without measurable disease in the serum, urine, or involved FLC: presence of 1 or more focus of extramedullary disease which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion \>=2 centimeter (cm) (at its greatest dimension) diameter on whole body positron emission tomography-computed tomography (or whole-body magnetic resonance imaging approved by sponsor), and not previously radiated Inclusion criteria for newly diagnosed amyloid light chain (ND AL) Amyloidosis * Have a histopathological diagnosis of amyloidosis * Have an ECOG performance status of 0 to 1 Inclusion criteria for High-risk smoldering multiple myeloma (SMM) * Have a diagnosis of SMM (per IMWG criteria) for less than or equal to (\<=) 5 years with measurable disease at the time of enrollment as defined in the protocol * Have an ECOG performance status of 0 to 1 Exclusion Criteria for NDMM and R/R MM: * 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 Exclusion Criteria for ND AL Amyloidosis * 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 * Prior therapy for AL amyloidosis or multiple myeloma Exclusion Criteria for High-risk SMM * Multiple myeloma, requiring treatment * Primary systemic AL (immunoglobulin light chain) amyloidosis Exclusion criteria for all participants: * 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 (%)
Where it's running
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Colorado Blood Cancer Institute
Denver, Colorado, United States Recruiting -
Winship Cancer Institute Emory University
Atlanta, Georgia, United States Recruiting -
Monash Medical Centre
Clayton, Australia Recruiting -
St Vincents Hospital Melbourne
Fitzroy, Australia Recruiting -
Peter MacCallum Cancer Centre
Melbourne, Australia Recruiting -
Calvary Mater Newcastle Hospital
Waratah, Australia Recruiting
Show 10 more locations
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Wollongong Hospital
Wollongong, Australia Recruiting -
Carmel Medical Center
Haifa, Israel Recruiting -
Hadassah Medical Center
Jerusalem, Israel Recruiting -
Sheba Medical Center
Ramat Gan, Israel Recruiting -
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel Recruiting -
VU Medisch Centrum
Amsterdam, Netherlands Recruiting -
Universitair Medisch Centrum Groningen
Groningen, Netherlands Recruiting -
UMC Utrecht
Utrecht, Netherlands Recruiting -
Hosp. Clinic de Barcelona
Barcelona, Spain Recruiting -
Hosp Clinico Univ de Salamanca
Salamanca, Spain Recruiting
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Tec Dara for newly diagnosed multiple myeloma with light chain amyloidosis
This study tests whether tec listamab plus daratumumab can help newly diagnosed multiple myeloma with AL amyloidosis and whether the combination is safe.
-
Maintaining myeloma with less frequent daratumumab plus lenalidomide
This phase 2 study tests a reduced-dosing schedule of daratumumab with lenalidomide to maintain remission in adults with multiple myeloma after stem cell transplant.
-
GR1803 injection versus daratumumab plus pomalidomide and dexamethasone for relapsed or refractory multiple myeloma
This trial tests whether GR1803 injection works better than daratumumab combined with pomalidomide and dexamethasone for adults with relapsed or refractory multiple myeloma who have had one to three prior treatments.
-
Prolonged overnight fasting combined with a Mediterranean-style diet for people with multiple myeloma or precursor conditions
This program will test whether longer overnight fasting paired with a Mediterranean-style eating plan is doable for adults with MGUS, smoldering myeloma, or newly diagnosed multiple myeloma who are starting treatment.
-
Belantamab Mafodotin or Daratumumab with VRd for Newly Diagnosed High-Risk Myeloma
This study tests whether belantamab mafodotin plus standard multiple myeloma drugs works better than daratumumab plus the same drugs for people newly diagnosed and ineligible for transplant.
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Etentamig plus daratumumab versus daratumumab‑lenalidomide‑dexamethasone for newly diagnosed multiple myeloma in patients not eligible for transplant
This trial will test whether adding the investigational drug etentamig to daratumumab helps control disease and is safe in adults newly diagnosed with multiple myeloma who cannot have a transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.