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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06768489




Registration number
NCT06768489
Ethics application status
Date submitted
23/12/2024
Date registered
10/01/2025
Date last updated
10/01/2025

Titles & IDs
Public title
A Study of JNJ-79635322 in Combination With Daratumumab or Pomalidomide for Multiple Myeloma
Scientific title
A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab or Pomalidomide for Multiple Myeloma
Secondary ID [1] 0 0
79635322MMY1002
Secondary ID [2] 0 0
79635322MMY1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-79635322
Treatment: Drugs - Daratumumab
Treatment: Drugs - Pomalidomide

Experimental: Treatment Regimen A: JNJ-79635322+Daratumumab - Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (Treatment regimen A1) will receive a dose of 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 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 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.

Experimental: Treatment Regimen B: JNJ-79635322+Pomalidomide - 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 a dose of 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.


Treatment: Drugs: JNJ-79635322
JNJ-79635322 will be administered subcutaneously.

Treatment: Drugs: Daratumumab
Daratumumab will be administered subcutaneously.

Treatment: Drugs: Pomalidomide
Pomalidomide will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
Timepoint [1] 0 0
Up to 3 Years and 3 months
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs) by Severity
Timepoint [2] 0 0
Up to 3 Years and 3 months
Primary outcome [3] 0 0
Number of Participants with Clinically Significant Laboratory Abnormalities
Timepoint [3] 0 0
Up to 3 Years and 3 months
Secondary outcome [1] 0 0
Percentage of Participants With Overall Response Rate
Timepoint [1] 0 0
Up to 3 Years and 3 months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 3 Years and 3 months
Secondary outcome [3] 0 0
Time to Response (TTR)
Timepoint [3] 0 0
Up to 3 Years and 3 months
Secondary outcome [4] 0 0
Serum Concentration of JNJ-79635322 and Daratumumab
Timepoint [4] 0 0
Up to 3 Years and 3 months
Secondary outcome [5] 0 0
Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUCinf) for JNJ-79635322 and Daratumumab
Timepoint [5] 0 0
Up to 3 Years and 3 months
Secondary outcome [6] 0 0
Area Under the Serum Concentration Time Curve from Time Zero to the Last Measurable Concentration [AUC(0-t)] for JNJ-79635322 and Daratumumab
Timepoint [6] 0 0
Up to 3 Years and 3 months
Secondary outcome [7] 0 0
Area Under the Serum Concentration Time Curve During the Dosing Interval (AUCtau) for JNJ-79635322 and Daratumumab
Timepoint [7] 0 0
Up to 3 Years and 3 months
Secondary outcome [8] 0 0
Maximum Serum Concentration (Cmax) for JNJ-79635322 and Daratumumab
Timepoint [8] 0 0
Up to 3 Years and 3 months
Secondary outcome [9] 0 0
Half Life (T1/2) for JNJ-79635322 and Daratumumab
Timepoint [9] 0 0
Up to 3 Years and 3 months
Secondary outcome [10] 0 0
Time to Reach Cmax (Tmax) for JNJ-79635322 and Daratumumab
Timepoint [10] 0 0
Up to 3 Years and 3 months
Secondary outcome [11] 0 0
Systemic Clearance (CL/F) for JNJ-79635322 and Daratumumab
Timepoint [11] 0 0
Up to 3 Years and 3 months
Secondary outcome [12] 0 0
Apparent Volume of Distribution at Steady State (Vss/F) for JNJ-79635322 and Daratumumab
Timepoint [12] 0 0
Up to 3 Years and 3 months
Secondary outcome [13] 0 0
Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 and Daratumumab
Timepoint [13] 0 0
Up to 3 Years and 3 months

Eligibility
Key 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
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
Israel
State/province [1] 0 0
Haifa
Country [2] 0 0
Israel
State/province [2] 0 0
Jerusalem
Country [3] 0 0
Israel
State/province [3] 0 0
Ramat Gan
Country [4] 0 0
Israel
State/province [4] 0 0
Tel Aviv Yafo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 either daratumumab or pomalidomide; and for Part 2 (Dose Expansion) is to further define the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).
Trial website
https://clinicaltrials.gov/study/NCT06768489
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06768489