Ramantamig plus Daratumumab vs standard regimens in newly diagnosed multiple myeloma without planned stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 trial, participants with newly diagnosed multiple myeloma who are not planned for autologous stem cell transplant will be randomized to receive ramantamig-D plus Daratumumab or standard regimens (DVRd or DRd). The main goals are to compare progression-free survival and the rate of 12-month MRD-negative complete responses. Eligible patients will have measurable disease, good performance status, and no conditions that would preclude high-dose therapy if later considered. Safety, tolerability, and treatment-emergent adverse events will be monitored. The study is sponsored by Janssen and will be conducted at multiple international sites.

Why it matters

Who can join: the full rules

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

Where it's running

• St Vincent s Hospital Sydney
  Darlinghurst, Australia Recruiting
• Mater Hospital Brisbane
  South Brisbane, Australia Recruiting
• Fakultni nemocnice Brno
  Brno, Czechia Recruiting
• Fakultni nemocnice Hradec Kralove
  Hradec Králové, Czechia Recruiting
• Fakultni Nemocnice Ostrava
  Ostrava, Czechia Recruiting
• Fakultni nemocnice Plzen
  Pilsen, Czechia Recruiting

+53 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.