Status:
RECRUITING
Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Canadian Cancer Trials Group
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Myeloma Canada
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Currently, daratumumab or isatuximab are given continuously (non-stop), along side lenalidomide, and dexamethasone as part of multiple myeloma treatment. are given continuously (non-stop). Recent obse...
Detailed Description
The usual approach for people with myeloma who are not having a stem cell transplant is treatment with daratumumab or isatuximab in combination with lenalidomide, and dexamethasone. These drugs are gi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2032
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT06182774
Start Date
April 10 2024
End Date
July 31 2032
Last Update
November 20 2025
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
BCCA - Kelowna
Kelowna, British Columbia, Canada, V1Y 5L3
2
BCCA - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
3
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
4
The Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8