Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT06182774
- Lead Sponsor
- Canadian Cancer Trials Group
- Brief Summary
Currently, daratumumab, lenalidomide, and dexamethasone are given continuously (non-stop). Some recent observations suggest that stopping daratumumab after about a year and a half of treatment may work just as well as giving it continuously with lenalidomide and dexamethasone. This study is being done to answer the question: is less daratumumab treatment as good as more?
- Detailed Description
The usual approach for people with myeloma who are not having a stem cell transplant is treatment with the combination of daratumumab, lenalidomide, and dexamethasone. These drugs are given continuously until they are no longer effective or cause major side effects.
Those that decide to take part in this study, will be randomly placed in one of two groups. If in the usual care group, patients will continue all the myeloma medicines currently being taken. If in the experimental group, patients will stop the daratumumab injection, and continue taking the myeloma tablets currently being taken. Regardless of which group, patients will stay on treatment indefinitely as long they are benefiting from it.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 559
- 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 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
- Received daratumumab-lenalidomide-dexamethasone for 18-20 cycles
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lenalidomide & Dexamethasone Dexamethasone - Daratumumab, Lenalidomide & Dexamethasone Dexamethasone Standard of Care Lenalidomide & Dexamethasone Lenalidomide - Daratumumab, Lenalidomide & Dexamethasone Daratumumab Standard of Care Daratumumab, Lenalidomide & Dexamethasone Lenalidomide Standard of Care
- Primary Outcome Measures
Name Time Method Progression-Free Survival 8.1 years PFS is defined as the time from date of enrollment to date of first documentation of disease progression
- Secondary Outcome Measures
Name Time Method Partial Response or Better as assessed by IMWG Criteria 8.1 years Time to Next Treatment 8.1 years Time from enrollment to the start of next-line treatment
Quality of Life Utilizing FACIT-COST 8.1 years Overall Survival 8.1 years Time from enrollment to death from any cause
Incidence of Treatment-Related Grade 3-5 Adverse Events and all infections based on CTCAE 5.0 8.1 years Post-protocol Therapy Documentation checklist 8.1 years Documentation of patients 2nd line treatment after treatment completion of daratumumab, lenalidomide, and dexamethasone
Quality of Life Utilizing EORTC QLQ-C30 8.1 years Health Economic Analyses Utilizing EQ-5D-5L 8.1 years Value is calculated by determining the incremental costs and benefits (life years, quality adjusted life years) across the two treatment arms from two perspectives, a health system and a societal perspective
Trial Locations
- Locations (24)
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
🇨🇦Quebec City, Quebec, Canada
BCCA - Kelowna
🇨🇦Kelowna, British Columbia, Canada
BCCA - Vancouver
🇨🇦Vancouver, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Regional Health Authority B, Zone 2
🇨🇦Saint John, New Brunswick, Canada
Royal Victoria Regional Health Centre
🇨🇦Barrie, Ontario, Canada
William Osler Health System
🇨🇦Brampton, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
Grand River Regional Cancer Centre
🇨🇦Kitchener, Ontario, Canada
London Health Sciences Centre Research Inc.
🇨🇦London, Ontario, Canada
Stronach Regional Health Centre at Southlake
🇨🇦Newmarket, Ontario, Canada
Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
Algoma District Cancer Program
🇨🇦Sault Ste. Marie, Ontario, Canada
Niagara Health System
🇨🇦St. Catharines, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
St. Joseph's Health Centre
🇨🇦Toronto, Ontario, Canada
CIUSSS de l'Est-de-I'lle-de-Montreal
🇨🇦Montreal, Quebec, Canada
The Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada