Ramantamig with daratumumab compared with standard treatment for newly diagnosed multiple myeloma
Compares ramantamig plus daratumumab with standard drugs in newly diagnosed multiple myeloma without planned transplant.
Key facts
- Who runs it
- Janssen Research & Development, LLC
- Where
- Bydgoszcz, Chorzów, Gdansk, Katowice, Kielce, Krakow, Lublin, Szczecin, and Wroclaw, PolandSee the 9 sitesAlso in 13 other countries, 94 sites
- Trial code
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,000 people, planned
- Started
- 9 Sept 2026
- Expected to end
- 2 Feb 2035
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ramantamig
- Daratumumab
- Lenalidomide
- Bortezomib
- Dexamethasone
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed multiple myeloma who are not planned for a stem cell transplant as first treatment and have not had treatment for it yet.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Newly diagnosed multiple myeloma with measurable disease; not considered for high-dose chemotherapy with stem cell transplant because of advanced age or other health conditions
- Earlier treatment
- No earlier treatment for multiple myeloma or smoldering myeloma, except a short course of corticosteroids in an emergency
- Biomarker or test result
- Measurable disease at screening, checked by a central laboratory
Main reasons for not taking part
- Myeloma Frailty Score of 2 or more (unless the score of 2 is from age alone)
- Known or suspected allergy or intolerance to any trial treatment
- Major surgery or serious injury within 2 weeks before the first dose, or surgery planned during the trial
- Active or past myeloma in the brain or spinal fluid area (CNS or meninges)
- Any earlier treatment for multiple myeloma or smoldering myeloma
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients
- 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
Where in Poland
Also in 13 other countries, 94 sites
- Jan Biziel's University HospitalBydgoszcz, PolandTaking people
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali MiejskichChorzów, PolandTaking people
- Uniwersyteckie Centrum Kliniczne Uniwersytet MedycznyGdansk, PolandTaking people
- Pratia Onkologia KatowiceKatowice, PolandTaking people
- Swietokrzyskie Centrum Onkologii SPZOZ w KielcachKielce, PolandTaking people
- Pratia MCM KrakowKrakow, PolandTaking people
- Uniwersytecki Szpital Kliniczny Nr 1 w LublinieLublin, PolandTaking people
- Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w SzczecinieSzczecin, PolandTaking people
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclaw, PolandTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Arm A: Ramantamig plus Daratumumab (Ramantamig-D)Treatment being tested
Participants will receive ramantamig D subcutaneous injection.
Treatment: Ramantamig and Daratumumab
- Arm B: Investigator's Choice (DVRd or DRd)Existing treatment, for comparison
Participants will receive either daratumumab, bortezomib, lenalidomide, dexamethasone (DVRd) or daratumumab, lenalidomide, dexamethasone (DRd) as per investigator's choice.
Treatment: Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 3 Randomized Study Comparing Ramantamig Plus Daratumumab Versus Investigator's Choice of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
- Plain-language title
- Ramantamig with daratumumab compared with standard treatment for newly diagnosed multiple myelomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 November 2026