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Comparing fixed duration and continuous daratumumab treatment for older adults with multiple myeloma

A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration Versus Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma

Phase 3 Interventional Canadian Cancer Trials Group · NCT06182774

This study is testing if older adults with newly diagnosed multiple myeloma can stop daratumumab treatment after 18-20 cycles and still get similar benefits as those who keep taking it continuously.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment570 (estimated)
Ages18 Years and up
SexAll
SponsorCanadian Cancer Trials Group Research network
Drugs / interventionsdaratumumab, isatuximab
Locations28 sites (Edmonton, Alberta and 27 other locations)
Trial IDNCT06182774 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether stopping daratumumab treatment after 18-20 cycles is as effective as continuous treatment in older adults with newly diagnosed multiple myeloma who are not eligible for a stem cell transplant. Participants will be randomly assigned to either continue their current treatment regimen or stop daratumumab while continuing with lenalidomide and dexamethasone. The goal is to determine if a fixed duration of daratumumab can provide similar benefits without the need for continuous administration. The study aims to enhance treatment strategies for this patient population.

Who should consider this trial

Good fit: Ideal candidates are older adults with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation and have shown a partial response to initial treatment.

Not a fit: Patients who are not newly diagnosed, those who are eligible for stem cell transplantation, or those who have not responded adequately to initial treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more manageable treatment regimen for older adults with multiple myeloma, potentially reducing side effects and healthcare costs.

How similar studies have performed: While the approach of fixed duration treatment is being explored, this specific comparison of daratumumab treatment duration has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants with newly diagnosed multiple myeloma that are transplant-ineligible
* Measurable disease at the time of diagnosis, as defined by at least one of the following criteria: Serum monoclonal protein (M-protein) ≥ 5 g/L; Urine M-protein ≥ 200 mg/24 hours; Involved serum free light chain measurement ≥ 100 mg/L, provided serum FLC ration is abnormal; For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin ≥ 750 mg/dL
* Completed 18-20 cycles of daratumumab-lenalidomide-dexamethasone or isatuximab-lenalidomide-dexamethasone.
* Obtained at least a partial response per the standard 2016 IMWG criteria
* ECOG performance status 0-3
* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in English, French, or a provided validated language.
* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
* Participants must be accessible for treatment and follow-up.
* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment.
* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.

Exclusion Criteria:

* Known history of concurrent amyloid light chain amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), and Waldenstrom's macroglobulinemia.
* Patients receiving concurrent treatment with other anti-cancer therapy that would impact the ability to comply with protocol treatment are ineligible. Note: Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of protocol treatment are eligible for this trial
* Active, uncontrolled bacterial, fungal, or viral infection within 7 days prior to enrollment.
* Known human immunodeficiency virus (HIV) with CD4 count \< 350 cells/microliter. Note that patients who are HIV positive are eligible, provided:

  * They are under treatment with antiretroviral therapy for at least 4 weeks prior to enrollment, with acceptable pharmacokinetic interactions and minimal overlapping toxicity with protocol therapy AND
  * HIV viral load must be \< 400 copies/ml within 16 weeks prior to enrollment AND
  * No history of opportunistic infections within the past year.

Where this trial is running

Edmonton, Alberta and 27 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.