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A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma
Clinicaltrials.gov:
EU CTIS:
#2024-513439-25-00
Other:
#87562761MMY1001
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Trials at a glance
Status
Enrolling
Condition
Relapsed or Refractory Multiple Myeloma
Trial type
Interventional
Trial phase
Phase 1
Investigational
product
product
JNJ-87562761
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
December 19, 2024
Trial end date
November 3, 2028
CT.gov ID
#NCT06604715
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-87562761 in Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to determine the recommended phase 2 dose(s) (RP2D[s]) of
JNJ-87562761 in Part 1 (dose escalation), and to determine the safety and tolerability at
RP2D in Part 2 (dose expansion) in participants with multiple myeloma (MM) whose disease
has come back after treatment (relapsed) or hasn't responded to treatment (refractory).
Primary outcome measures
- Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
- Part 1 and 2: Number of Participants with Adverse Events (AEs)
- Part 2: Number of Participants with Clinically Significant Abnormal Laboratory Values
Secondary outcome measures
- Serum Concentration of JNJ-87562761
- Pharmacokinetic (PK) Parameters of JNJ-87562761
- Number of Participants with Presence of Anti-JNJ-87562761 Antibodies
- Percentage of Participants with Response
- Percentage of Participants Who Achieve Very Good Partial Response (VGPR) or Better
- Percentage of Participants Who Achieve Complete Response (CR) or Better
- Percentage of Participants Who Achieve Stringent Complete Response (sCR)
- Duration of Response (DOR)
- Time to Response (TTR)
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