NCT06768489RecruitingPhase 1
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 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
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 276 (estimated)
- First submitted
- 23 Dec 2024
- Start date
- 4 Dec 2024
- Primary completion date
- 2 Jan 2029
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Amyloidosis, Multiple myeloma
- NCT number
- NCT06768489
- EU CT number
- 2024-515316-44-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 276
- From 4 Dec 2024 to the primary completion date, 2 Jan 2029
- 16 sites in 5 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
- 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
- Prior therapy for AL amyloidosis or multiple myeloma
- 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
Other illness
- Known or suspected chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (\<) 50 percent (%)
Other
- Macroglossia that impairs swallowing difficulty
- Multiple myeloma, requiring treatment
- Primary systemic AL (immunoglobulin light chain) amyloidosis
Who the study is looking for
- 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
- Have a histopathological diagnosis of amyloidosis
- Have an ECOG performance status of 0 to 1
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Medical Centre Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| St Vincents Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Recruiting |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Calvary Mater Newcastle Hospital Coordinator of this site? Confirm its status | Waratah | Australia | Recruiting |
| Wollongong Hospital Coordinator of this site? Confirm its status | Wollongong | Australia | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Winship Cancer Institute, Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.