Recruiting NCT07518186
A Study Comparing JNJ-79635322 and Teclistamab 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, Teclistamab.
- 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, Australia, China, France, Germany +10
- 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 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide
Overview
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
Interventions
- Drug JNJ-79635322
JNJ-79635322 will be administered as SC injection. - Drug Teclistamab
Teclistamab will be administered as SC injection.
Primary outcome measures
- Complete Response (CR) or Better [Time frame: Up to approximately 41 months]
- Progression-Free Survival (PFS) [Time frame: Up to approximately 41 months]
Secondary outcome measures (12)
- Overall Response Rate (ORR) [Time frame: Up to approximately 41 months]
- Very Good Partial Response (VGPR) or Better [Time frame: Up to approximately 41 months]
- Duration of Response (DoR) [Time frame: Up to approximately 41 months]
- Minimal Residual Disease (MRD)-negative CR [Time frame: Up to approximately 41 months]
- MRD-negative CR at 1 Year [Time frame: At 1 Year]
- MRD-negative CR at 5 Years [Time frame: At 5 Years]
- Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2) [Time frame: Up to approximately 41 months]
- Overall Survival (OS) [Time frame: Up to approximately 41 months]
- Time To Next Line of Therapy (TTNT) [Time frame: Up to approximately 41 months]
- Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity [Time frame: Up to approximately 41 months]
- Number of Participants with Abnormalities in Laboratory Parameters [Time frame: Up to approximately 41 months]
- Change from Baseline in Health-related Quality of Life (HRQoL), Symptoms and Functioning using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Scores [Time frame: From Baseline up to approximately 41 months]
Eligibility criteria
Inclusion criteria
- Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory
- Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication
- Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment
Exclusion criteria
- Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients
- Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM
- Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 26 centers
- Alabama Oncology — Birmingham
- Mayo Clinic 1 — Phoenix
- Highlands Oncology Group — Springdale
- Beverly Hills Cancer Center Clinical Research Advisors LLC — Beverly Hills
- Valkyrie Clinical Trials — Los Angeles
- Mayo Clinic Jacksonville — Jacksonville
- Memorial Cancer Institute — Pembroke Pines
- Emory University — Atlanta
- … and 18 more centers
Japan · 8 centers
- National Hospital Organization Kyushu Medical Center — Fukuoka
- Gunma University Hospital — Gunma
- University Hospital Kyoto Prefectural University of Medicine — Kyoto
- Matsuyama Red Cross Hospital — Matsuyama
- National Hospital Organization Okayama Medical Center — Okayama
- Sapporo City General Hospital — Sapporo
- The Cancer Institute Hospital of JFCR — Tokyo
- Kanagawa Cancer Center — Yokohama
Spain · 8 centers
- Hosp. Clinic de Barcelona — Barcelona
- Hosp. San Pedro de Alcantara — Cáceres
- Hosp Reina Sofia — Córdoba
- Hosp. de Jerez de La Frontera — Jerez de la Frontera
- Hosp. Univ. 12 de Octubre — Madrid
- Clinica Univ. de Navarra — Pamplona
- Hosp. Univ. Marques de Valdecilla — Santander
- Hosp. Virgen Del Rocio — Seville
Turkey (Türkiye) · 8 centers
Center list to be confirmed — check the primary protocol.
Israel · 6 centers
- Samson Assuta Ashdod University Hospital — Ashdod
- Rambam Med.Center - Hematology Institute — Haifa
- Carmel Medical Center — Haifa
- Rabin Medical Center — Petah Tikva
- Sheba Medical Center — Ramat Gan
- Tel Aviv Sourasky Medical Center — Tel Aviv
South Korea · 5 centers
- Seoul National University Bundang Hospital — Gyeonggi-do
- Chonnam National University Hwasun Hospital — Hwasun
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
- The Catholic University of Korea Seoul St Marys Hospital — Seoul
Taiwan · 5 centers
- China Medical University Hospital — Taichung
- Taichung Veterans General Hospital — Taichung
- National Cheng Kung University Hospital — Tainan
- National Taiwan University Hospital — Taipei
- Taipei Veterans General Hospital — Taipei
Greece · 4 centers
- Evangelismos S A — Athens
- Alexandra General Hospital of Athens — Athens
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara — Athens
- University General Hospital of Ioannina — Ioannina
Poland · 4 centers
- Pratia Onkologia Katowice — Katowice
- Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli — Lublin
- MTZ Clinical Research Powered by Pratia — Warsaw
- Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu — Wałbrzych
France · 3 centers
- CHU Nantes - Hotel Dieu — Nantes
- CHU Toulouse — Toulouse
- CHRU de Tours — Tours
Germany · 3 centers
- Universitaetsklinikum Freiburg — Freiburg im Breisgau
- Asklepios Klinik Altona — Hamburg
- Universitaetsklinik Tuebingen — Tübingen
India · 3 centers
- Bhagwan Mahaveer Cancer Hospital & Research Centre — Jaipur
- Nil Ratan Sircar Medical College and Hospital — Kolkata
- Deenanath Mangeshkar Hospital and Research Centre — Pune
China · 2 centers
- Beijing Chaoyang Hospital — Chaoyang District
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tijian
Italy · 2 centers
- Azienda Ospedaliero Universitaria Maggiore della Carita di Novara — Novara
- Casa di Cura La Maddalena — Palermo
Australia · 1 center
- St Vincent s Hospital Sydney — Darlinghurst
Identifiers
NCT: NCT07518186 · 79635322MMY3002