Multiple Myeloma
Conditions
Brief summary
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.
Interventions
JNJ-79635322 will be administered as an injection under the skin.
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion: * Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: 1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria 2. Measurable disease at screening as assessed by central laboratory * Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD) 38 monoclonal antibody (mAb) * Documented evidence of progressive disease(PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by the IMWG criteria * Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent * Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 to 2 at screening and immediately before the start of study treatment administration Exclusion: * Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322 * Had major surgery within 2 weeks before first dose or has planned major surgery during study treatment phase * Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM * Participant has leptomeningeal disease * Participant has a prior or concurrent second malignancy the natural history or treatment of which could likely interfere with any study endpoints of safety or the efficacy of the study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) | Up to 2 years and 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Very Good Partial Response (VGPR) or Better Rate | Up to 2 years and 9 months |
| Complete Response (CR) or Better Rate | Up to 2 years and 9 months |
| Duration of Response (DoR) | Up to 2 years and 9 months |
| Progression-Free Survival (PFS) | Up to 2 years and 9 months |
| Overall Survival (OS) | Up to 2 years and 9 months |
| Time To Next Line of Therapy (TTNT) | Up to 2 years and 9 months |
| Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity | 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 | 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 | From Baseline up to 2 years and 9 months |
| 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 | From Baseline up to 2 years and 9 months |
| Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q | Up to 2 years and 9 months |
| Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 | Up to 2 years and 9 months |
| Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L | Up to 2 years and 9 months |
| Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q | Up to 2 years and 9 months |
| Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 | Up to 2 years and 9 months |
| Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L | Up to 2 years and 9 months |
| Serum Concentrations for JNJ-79635322 | Up to 2 years and 9 months |
| Number of Participants With Anti JNJ-79635322 Antibodies | Up to 2 years and 9 months |
| Number of Participants With JNJ-79635322 Neutralizing Antibodies (NAb) | Up to 2 years and 9 months |
Countries
Israel, Japan, United States