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 observations suggest that stopping daratumumab or isatuximb after about a year and a half of treatment may work just as well as giving them continuously with lenalidomide and dexamethasone. Sometimes, bortezomib is also given. This study is being done to answer the question: is less daratumumab or isatuximab treatment as good as more?
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 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 or isatuximab 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
570
Dose determined at enrollment
Dose determined at enrollment
Dose determined at enrollment
Dose determined at enrollment
Cross Cancer Institute
Edmonton, Alberta, Canada
RECRUITINGBCCA - Kelowna
Kelowna, British Columbia, Canada
RECRUITINGBCCA - Vancouver
Vancouver, British Columbia, Canada
RECRUITINGCancerCare Manitoba
Winnipeg, Manitoba, Canada
Progression-Free Survival
PFS is defined as the time from date of enrollment to date of first documentation of disease progression
Time frame: 9.1 years
Overall Survival
Time from enrollment to death from any cause
Time frame: 9.1 years
Partial Response or Better as assessed by IMWG Criteria
Time frame: 9.1 years
Incidence of Treatment-Related Grade 3-5 Adverse Events and all infections based on CTCAE 5.0
Time frame: 9.1 years
Time to Next Treatment
Time from enrollment to the start of next-line treatment
Time frame: 9.1 years
Post-protocol Therapy Documentation checklist
Documentation of patients 2nd line treatment after treatment completion of daratumumab, or isatuximab, lenalidomide, and dexamethasone
Time frame: 9.1 years
Quality of Life Utilizing EORTC QLQ-C30
Time frame: 9.1 years
Quality of Life Utilizing FACIT-COST
Time frame: 9.1 years
Health Economic Analyses Utilizing EQ-5D-5L
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
Time frame: 9.1 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Moncton Hospital
Moncton, New Brunswick, Canada
RECRUITINGRegional Health Authority B, Zone 2
Saint John, New Brunswick, Canada
RECRUITINGDr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
RECRUITINGRoyal Victoria Regional Health Centre
Barrie, Ontario, Canada
RECRUITINGWilliam Osler Health System
Brampton, Ontario, Canada
RECRUITINGJuravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
RECRUITING...and 19 more locations