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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
157
JNJ-79635322 will be administered as an injection under the skin.
Overall Response Rate (ORR)
Time frame: Up to 2 years and 9 months
Very Good Partial Response (VGPR) or Better Rate
Time frame: Up to 2 years and 9 months
Complete Response (CR) or Better Rate
Time frame: Up to 2 years and 9 months
Duration of Response (DoR)
Time frame: Up to 2 years and 9 months
Progression-Free Survival (PFS)
Time frame: Up to 2 years and 9 months
Overall Survival (OS)
Time frame: Up to 2 years and 9 months
Time To Next Line of Therapy (TTNT)
Time frame: Up to 2 years and 9 months
Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
Time frame: Up to 2 years and 9 months
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
Time frame: From Baseline up to 2 years and 9 months
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
Time frame: From Baseline up to 2 years and 9 months
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O Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, United States
ACTIVE_NOT_RECRUITINGBanner MD Anderson Cancer Center
Gilbert, Arizona, United States
ACTIVE_NOT_RECRUITINGCity of Hope
Duarte, California, United States
ACTIVE_NOT_RECRUITINGCity of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
ACTIVE_NOT_RECRUITINGCancer and Blood Specialty Clinic
Los Alamitos, California, United States
ACTIVE_NOT_RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
ACTIVE_NOT_RECRUITINGRocky Mountain Cancer Centers
Aurora, Colorado, United States
RECRUITINGColorado Blood Cancer Institute
Denver, Colorado, United States
ACTIVE_NOT_RECRUITINGCancer Specialists of North Florida
Jacksonville, Florida, United States
ACTIVE_NOT_RECRUITINGEmory University
Atlanta, Georgia, United States
ACTIVE_NOT_RECRUITING...and 61 more locations
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 frame: From Baseline up to 2 years and 9 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q
Time frame: Up to 2 years and 9 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
Time frame: Up to 2 years and 9 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L
Time frame: Up to 2 years and 9 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q
Time frame: Up to 2 years and 9 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
Time frame: Up to 2 years and 9 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L
Time frame: Up to 2 years and 9 months
Serum Concentrations for JNJ-79635322
Time frame: Up to 2 years and 9 months
Number of Participants With Anti JNJ-79635322 Antibodies
Time frame: Up to 2 years and 9 months
Number of Participants With JNJ-79635322 Neutralizing Antibodies (NAb)
Time frame: Up to 2 years and 9 months