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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
Immunoglobulin Light-chain Amyloidosis
Multiple Myeloma
Smoldering Multiple Myeloma
Clinicaltrials.gov:
EU CTIS:
#2024-515316-44-00
Other:
#79635322MMY1002
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Trials at a glance
Status
Enrolling
Condition
Immunoglobulin Light-chain Amyloidosis
Multiple Myeloma
Smoldering Multiple Myeloma
Trial type
Interventional
Trial phase
Phase 1
Investigational
product
product
Daratumumab
JNJ-79635322
Lenalidomide
Pomalidomide
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
December 4, 2024
Trial end date
June 29, 2029
CT.gov ID
#NCT06768489
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
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
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).
Primary outcome measures
- Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
- Number of Participants with Adverse Events (AEs) by Severity
- Number of Participants with Clinically Significant Laboratory Abnormalities
Secondary outcome measures
- Percentage of Participants With Overall Response Rate
- Percentage of Participants With Very Good Partial Response (VGPR) or Better Response Rate
- Percentage of Participants With CR or Better Response Rate
- Percentage of Participants With sCR or Better Response Rate
- Duration of Response (DOR)
- Time to Response (TTR)
- Percentage of Participants With Hematologic Response As Defined by International Amyloidosis Consensus Criteria
- DOR as Defined by International Amyloidosis Consensus Criteria
- TTR as Defined by International Amyloidosis Consensus Criteria
- Serum Concentration of JNJ-79635322 and Daratumumab
- Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUCinf) for JNJ-79635322 and Daratumumab
- Area Under the Serum Concentration Time Curve from Time Zero to the Last Measurable Concentration [AUC(0-t)] for JNJ-79635322 and Daratumumab
- Area Under the Serum Concentration Time Curve During the Dosing Interval (AUCtau) for JNJ-79635322 and Daratumumab
- Maximum Serum Concentration (Cmax) for JNJ-79635322 and Daratumumab
- Half Life (T1/2) for JNJ-79635322 and Daratumumab
- Time to Reach Cmax (Tmax) for JNJ-79635322 and Daratumumab
- Systemic Clearance (CL/F) for JNJ-79635322 and Daratumumab
- Apparent Volume of Distribution at Steady State (Vss/F) for JNJ-79635322 and Daratumumab
- Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 and Daratumumab
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