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
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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; or iii. deferral of high-dose chemotherapy with ASCT as initial treatment
* 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 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 time from treatment assignment (that is, randomization in the trial) to 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 achieving MRD-negative status at the analysis time window of 12 months (+/-3 months), as determined by next-generation sequencing (NGS) with sensitivity of 10\^-5, prior to PD or subsequent antimyeloma therapy (including ASCT). Additionally, CR or better must be achieved any time from randomization up to and including 12+3 months, according to international myeloma working group (IMWG) criteria.
Trial sites (19)
Facility
City
Region
Status
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
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
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
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.
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