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RecruitingLast updated: 22 January 2025

A study recruiting people with multiple myeloma to identify the safe and effective dose of a new drug when given in combination with other treatmentsA Phase 1b Study of JNJ-79635322 in Combination With Daratumumab or Pomalidomide for Multiple Myeloma

Clinical summary

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 dosing schedule for a new drug called JNJ-79635322 treatment regimen in combination with either daratumumab or pomalidomide; and Part 2 (Dose Expansion) is to further define the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).

Eligible participants will be assigned to one of two treatment arms, depending on whether they have had prior treatment or not.

In the Experimental Treatment Regimen A arm, participants will receive JNJ-79635322 + Daratumumab targeted therapy.

Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulating drug (Treatment regimen A1) will receive a dose of JNJ-79635322 subcutaneously along with daratumumab (both given subcutaneously, which means as injections under the skin) to establish the RP2Ds of the JNJ-79635322 during Part 1 of the study. 

Based on the study evaluation team (SET) decision, enrollment may proceed in participants with newly diagnosed multiple myeloma (NDMM) (Treatment Regimen A2). 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 treatmen 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.

In the Experimental Treatment Regimen B arm, participants will receive JNJ-79635322 + pomalidomide targeted therapy.

Participants who have received great 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 a dose of JNJ-79635322 along with pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 of the study.

Dose escalation and de-escalation will be based on SET evaluation.

In Part 2, participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part  and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.

Conditions

This trial is treating patients with multiple myeloma, who either have or have not had prior treatment

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT06768489
  • 79635322MMY1002; 79635322MMY1002; 2024-515316-44-00

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab or Pomalidomide for Multiple Myeloma

Eligibility

Inclusion

  • 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
  • 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

  • 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 etcetera)
  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

There may be additional criteria to what is listed here, speak to your doctor to confirm whether this trial is right for you.

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