Evaluating a treatment-free interval for newly diagnosed multiple myeloma patients

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

This clinical trial investigates the feasibility of a treatment-free interval for patients with newly diagnosed multiple myeloma who have been treated with a combination of daratumumab, lenalidomide, and dexamethasone. The study aims to determine whether temporarily stopping treatment can maintain disease control while reducing side effects and improving quality of life. Participants will be monitored for disease progression and overall health outcomes after discontinuation of therapy. The trial is conducted in various locations across the Netherlands.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient was diagnosed with MM, based on the IMWG criteria, and measurable disease at the time of diagnosis (appendix A).
* Age ≥ 18 years.
* Patient was treated with 12 cycles (13 cycles is accepted) of Dara-Rd and will continue treatment with Dara-Rd. Reduced dosing of lenalidomide, but not to less than 5 mg, and previous discontinuation or dose reduction of dexamethasone is allowed.
* Partial response or better after treatment with 12 cycles of Dara-Rd, without signs of biochemical progression.
* ANC ≥ 1.0x109/L and platelets ≥ 75x109/L.
* Patient is capable of giving informed consent.
* Written informed consent.

Exclusion Criteria:

* Patient with non-secretory MM at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd.
* Patient in whom a plasmacytoma was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd.
* Patient in whom urine M-protein was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with Dara-Rd.
* Patient in whom treatment with daratumumab, lenalidomide or both has been discontinued for whatever reason (patients may only have discontinued dexamethasone).
* Patient in whom continuation of treatment with Dara-Rd is deemed not feasible because of medical reasons.
* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Where it's running

• NL-Den Bosch-JBZ
  's-Hertogenbosch, Netherlands Recruiting
• NL-Almere-FLEVOZIEKENHUIS
  Almere Stad, Netherlands Recruiting
• NL-Amersfoort-MEANDERMC
  Amersfoort, Netherlands Recruiting
• NL-Amsterdam- UMC
  Amsterdam, Netherlands Recruiting
• NL-Amsterdam-AmsterdamUMC
  Amsterdam, Netherlands Recruiting
• NL-Apeldoorn-GELREAPELDOORN
  Apeldoorn, Netherlands Recruiting

Study contacts

• Principal investigator: Sonja Zweegman, Prof Dr MD — Amsterdam UMC
• Study coordinator: Sonja Zweegman, Prof Dr MD
• Email: s.zweegman@amsterdamumc.nl
• Phone: 0031 20 4442604

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Belantamab Mafodotin or Daratumumab with VRd for Newly Diagnosed High-Risk Myeloma

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• Etentamig plus daratumumab versus daratumumab‑lenalidomide‑dexamethasone for newly diagnosed multiple myeloma in patients not eligible for transplant

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• Linvoseltamab versus standard daratumumab‑lenalidomide‑dexamethasone for adults with newly diagnosed, transplant‑ineligible multiple myeloma

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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.