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

FeAsiBility of a Treatment Free Interval in Newly Diagnosed mUltiple myeLOma Patients Treated With DaratumUmab-Lenalidomide-DexamethaSone- the FABULOUS Study. A Nationwide Open-label Randomized Phase III Clinical Trial Comparing Daratumumab-lenalidomide-dexamethasone Continuously Versus Including a Treatment Free Interval

Phase 3 Interventional Stichting Hemato-Oncologie voor Volwassenen Nederland · NCT06187441

This study is testing if taking a break from treatment can help newly diagnosed multiple myeloma patients manage their disease while feeling better and having fewer side effects.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment599 (estimated)
Ages18 Years and up
SexAll
SponsorStichting Hemato-Oncologie voor Volwassenen Nederland Academic / other
Drugs / interventionsdaratumumab
Locations38 sites ('s-Hertogenbosch and 37 other locations)
Trial IDNCT06187441 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with multiple myeloma and have shown a partial response or better after 12 cycles of daratumumab-lenalidomide-dexamethasone.

Not a fit: Patients with non-secretory multiple myeloma or those whose only measurable parameter at diagnosis was a plasmacytoma or urine M-protein may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the quality of life for multiple myeloma patients by reducing treatment-related side effects.

How similar studies have performed: While the concept of treatment-free intervals is being explored, this specific approach in multiple myeloma has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

's-Hertogenbosch and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Myeloma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.