Recruiting NCT07266441
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JNJ-79635322.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China, Israel, Italy, Japan +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Open-label Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody
Overview
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
- Drug JNJ-79635322
JNJ-79635322 will be administered as an injection under the skin.
Primary outcome measures
- Overall Response Rate (ORR) [Time frame: Up to 2 years and 9 months]
Secondary outcome measures (12)
- 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]
- 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]
Eligibility criteria
Inclusion:
- Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:
- MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 30 centers
- O Neal Comprehensive Cancer Center at UAB — Birmingham
- Banner MD Anderson Cancer Center — Gilbert
- City of Hope — Duarte
- City of Hope Orange County Lennar Foundation Cancer Center — Irvine
- Cancer and Blood Specialty Clinic — Los Alamitos
- University of California San Francisco — San Francisco
- Rocky Mountain Cancer Centers — Aurora
- Colorado Blood Cancer Institute — Denver
- … and 22 more centers
Italy · 9 centers
- ASST Papa Giovanni XXIII Bergamo — Bergamo
- Policlinico Sant'Orsola Malpighi — Bologna
- Azienda Ospedaliera S Croce e Carle Cuneo — Cuneo
- Azienda Ospedaliero Universitaria Careggi — Florence
- Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone — Palermo
- IRCCS Policlinico San Matteo, Università degli studi di Pavi — Pavia
- Presidio Ospedaliero Pescara — Pescara
- AOU Policlinico Umberto I — Roma
- … and 1 more center
Poland · 8 centers
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza — Brzozów
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach — Kielce
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie — Krakow
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi — Lodz
- Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie — Lublin
- Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan
- Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu — Torun
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu — Wroclaw
Israel · 6 centers
- Ha'Emek Medical Center — Afula
- Samson Assuta Ashdod University Hospital — Ashdod
- Hillel Yaffe Medical Center — Hadera
- Hadassah Medical Center — Jerusalem
- Rabin Medical Center — Petah Tikva
- Tel Aviv Sourasky Medical Center — Tel Aviv
South Korea · 6 centers
- Chonnam National University Hwasun Hospital — Jeollanam-do
- Seoul National University Hospital — Seoul
- Severance Hospital Yonsei University Health System — Seoul
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
- The Catholic University of Korea Seoul St Marys Hospital — Seoul
Turkey (Türkiye) · 6 centers
- Ankara University Medical Faculty — Ankara
- Liv Hospital Ankara — Ankara
- Memorial Antalya Hospital — Antalya
- Medipol University Hospital — Istanbul
- Istanbul Florance Nightingale Hospital — Istanbul
- Sakarya Üniversitesi Tıp Fakültesi Hastanesi — Sakarya
China · 4 centers
- Peking Union Medical College Hospital — Beijing
- Beijing Chaoyang Hospital — Chaoyang District
- Sun Yat Sen University Cancer Center — Guangzhou
- Shanghai Fourth People s Hospital — Shanghai
Japan · 2 centers
- National Hospital Organization Shibukawa Medical Center — Gunma
- National Hospital Organization Okayama Medical Center — Okayama
Identifiers
NCT: NCT07266441 · 79635322MMY2001 · 79635322MMY2001 · 2025-521976-80-00