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

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Cross Cancer Institute
  Edmonton, Alberta, Canada Recruiting
• BCCA - Kelowna
  Kelowna, British Columbia, Canada Recruiting
• BCCA - Vancouver
  Vancouver, British Columbia, Canada Recruiting
• CancerCare Manitoba
  Winnipeg, Manitoba, Canada Recruiting
• The Moncton Hospital
  Moncton, New Brunswick, Canada Recruiting
• Regional Health Authority B, Zone 2
  Saint John, New Brunswick, Canada Recruiting

Study contacts

• Study coordinator: Annette Hay
• Email: ahay@ctg.queensu.ca
• Phone: 613-533-6430

Similar studies

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

• 6MW5311 in adults with relapsed or refractory blood cancers

  This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.

  Recruiting Phase 1 Mabwell (Shanghai) Bioscience Co., Ltd. · Shanghai, Shanghai Municipality · NCT07914556

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

• Aspirin vs. rivaroxaban for blood clot prevention in newly diagnosed multiple myeloma

  In newly diagnosed multiple myeloma patients on IMiD-based therapy, this study tests whether aspirin or rivaroxaban is better at preventing blood clots.

  Recruiting Phase 4 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07907211

• Exercise phenotyping before chemotherapy in newly diagnosed multiple myeloma

  This observational study tests whether some newly diagnosed multiple myeloma patients with normal resting heart function already show limited exercise capacity, and whether that limitation relates to subtle heart tissue changes and future heart-related outcomes.

  Recruiting Technical University of Munich · Munich, Bavaria · NCT07851493

• SMS text check-ins to track symptoms for people with plasma cell disorders

  This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07850284

• Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma

  This study tests if Cevostamab combined with pomalidomide and dexamethasone can help people with multiple myeloma who have already had CAR T therapy and several prior treatments.

  Recruiting at 5 sites Phase 2 Hoffmann-La Roche · Nuremberg, Bavaria and 4 other locations · NCT07825064

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.