Clinical Trials in South Korea / NCT07665450
Recruiting
Phase 3
A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned
NCT07665450 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Multiple Myeloma
Investigational drug(s) / intervention(s)
Ramantamig: Ramantamig will be administered subcutaneously.
Daratumumab: Daratumumab will be administered subcutaneously.
Lenalidomide: Lenalidomide will be administered orally.
Bortezomib: Bortezomib will be administered subcutaneously or intravenously.
Dexamethasone: Dexamethasone will be administered orally or intravenously.
Study summary
The main purpose of this study is to see how well a new treatment ramantamig-D works compared to standard treatments that is either DVRd or DRd on progression-free survival (PFS; time until a participant's disease worsens) and 12-month minimal residue disease (MRD)-negative complete response (CR) rate (percentage of participants in whom cancer cells are not detected) in participants with newly diagnosed multiple myeloma (NDMM; an initial stage of blood cancer that forms in a type of white blood cells \[WBCs\] called plasma cells) for whom stem cell transplant is not planned as initial therapy.
Eligibility
Inclusion criteria:
* Documented diagnosis of multiple myeloma (MM) according to the IMWG diagnostic criteria
* Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: i. ineligible due to advanced age; or ii. ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT
* Have an eastern cooperative oncology status (ECOG) performance status of 0 to 2
* Must sign an informed consent form (ICF)
* Measurable disease at screening as assessed by central laboratory as defined in the protocol
Exclusion criteria:
* Myeloma Frailty Score of greater than or equal to (\>=) 2 with the exception of participants who have a score of 2 based on age alone
* Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients
* Had major surgery (for example, requiring general anesthesia) or had significant traumatic injury within 2 weeks prior to first dose of trial intervention or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the trial
* Known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM
* Received any prior therapy(ies) for treatment of MM or smoldering myeloma, with the exception of emergency use of a short course of corticosteroids
Primary outcome measure(s)
- Progression-Free Survival (PFS) — Up to approximately 62 months
PFS is defined as the duration from randomization to either confirmed progression of disease (PD) or death, whichever occurs first. - Percentage of Participants Achieving 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR) — Up to 12 months
12-month MRD-negative CR rate is defined as participants who achieve MRD-negative status at 12 months (+/-3 months) from randomization, as determined by next-generation sequencing (NGS), prior to PD or subsequent antimyeloma therapy (including ASCT). Additionally, participant must achieve CR or better any time from randomization up to and including 12+3 months prior to PD or subsequent antimyeloma therapy, according to international myeloma working group (IMWG) criteria.
Trial sites (30)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Nantes | Nantes | France | Recruiting |
| CHU Lyon Sud | Pierre-Bénite | France | Recruiting |
| Evangelismos S A | Athens | Greece | Recruiting |
| Alexandra General Hospital of Athens | Athens | Greece | Recruiting |
| Rambam Med.Center - Hematology Institute | Haifa | Israel | Recruiting |
| Carmel Medical Center | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center | Jerusalem | Israel | Recruiting |
| Rabin Medical Center | Petah Tikva | Israel | Recruiting |
| Sheba Medical Center | Ramat Gan | Israel | Recruiting |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | Recruiting |
| Sint Antonius Ziekenhuis | Nieuwegein | Netherlands | Recruiting |
| Pratia Onkologia Katowice | Katowice | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie | Lublin | Poland | Recruiting |
| The Catholic University of Korea Eunpyeong St Marys Hospital | Seoul | South Korea | Recruiting |
| Asan Medical Center | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| The Catholic University of Korea Seoul St Mary s Hospital | Seoul | South Korea | Recruiting |
| Hosp. Univ. Infanta Leonor | Madrid | Spain | Recruiting |
| Hosp. Univ. Dr. Peset | Valencia | Spain | Recruiting |
| Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi | Ankara | Turkey (Türkiye) | Recruiting |
| Liv Hospital Ankara | Ankara | Turkey (Türkiye) | Recruiting |
| Memorial Antalya Hastanesi | Antalya | Turkey (Türkiye) | Recruiting |
| Akdeniz Universitesi Tip Fakultesi | Antalya | Turkey (Türkiye) | Recruiting |
| Medipol Mega University Hospital | Istanbul | Turkey (Türkiye) | Recruiting |
| Istanbul Florence Nightingale Hastanesi | Istanbul | Turkey (Türkiye) | Recruiting |
| Izmir Tinaztepe Universitesi Ozel Galen Hastanesi | Izmir | Turkey (Türkiye) | Recruiting |
| Ondokuz Mayis University | Samsun | Turkey (Türkiye) | Recruiting |
| Blackpool Victoria Hospital | Blackpool | United Kingdom | Recruiting |
| Addenbrooke's Hospital | Cambridge | United Kingdom | Recruiting |
| Kent and Canterbury Hospital | Canterbury | United Kingdom | Recruiting |
More Janssen Research & Development, LLC trials in South Korea
Other trials for the same condition
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Active, not recruiting
Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07665450 on ClinicalTrials.gov ↗ ← All trials in South Korea