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A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma
Clinicaltrials.gov:
EU CTIS:
#2025-521976-80-00
Other:
#79635322MMY2001
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A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate how well JNJ-79635322 works (efficacy) in participants with Relapsed or Refractory Multiple Myeloma (RRMM; a cancer that forms in a type of white blood cells called a plasma cell. Cancer is called relapsed if it comes back after treatment and is called 'refractory' if does not respond to treatment) who have received at least 3 prior lines of therapy.

Primary outcome measures

  • Overall Response Rate (ORR)

Secondary outcome measures

  • Very Good Partial Response (VGPR) or Better Rate
  • Complete Response (CR) or Better Rate
  • Duration of Response (DoR)
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Time To Next Line of Therapy (TTNT)
  • Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
  • Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
  • Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
  • Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Score
  • Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q
  • Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
  • Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L
  • Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q
  • Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
  • Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L
  • Serum Concentrations for JNJ-79635322
  • Number of Participants With Anti JNJ-79635322 Antibodies
  • Number of Participants With JNJ-79635322 Neutralizing Antibodies (NAb)
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