Combining JNJ-79635322 with Daratumumab or Pomalidomide for Multiple Myeloma Treatment

A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma

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
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Janssen Research & Development, LLC (Industry-sponsored)
• Drugs / interventions: daratumumab, chimeric antigen receptor, chemotherapy
• Locations: 14 sites (Clayton and 13 other locations)
• Trial ID: NCT06768489 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults with documented multiple myeloma who have received prior therapies or are newly diagnosed and treatment-naïve.

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.

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 performed: Other studies have shown promising results with similar combination therapies in multiple myeloma, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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 regimen A1: 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 regimen A2: 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

Exclusion Criteria:

* Any serious underlying medical conditions, such as: a) Evidence of active viral, bacterial, or systemic fungal infection requiring ongoing antiviral, antibacterial, or antifungal treatment. b) Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. c) Cardiac conditions (myocardial infarction, unstable angina, or coronary artery bypass graft \<=6 months prior to enrollment; New york heart association stage III or IV congestive heart failure et cetera)
* 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 regimen A 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 less than or equal to (\<=)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
* The following medical conditions: 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

Where this trial is running

Clayton and 13 other locations

• 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)
• 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

Conditions Multiple Myeloma