Actively Recruiting
Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma
Led by Canadian Cancer Trials Group · Updated on 2026-05-12
570
Participants Needed
28
Research Sites
433 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with newly diagnosed multiple myeloma who are transplant-ineligible
- Measurable disease at diagnosis defined by one or more of: Serum monoclonal protein 65 5 g/L; Urine M-protein 65 200 mg/24 hours; Involved serum free light chain 65 100 mg/L with abnormal ratio; IgA patients with serum quantitative immunoglobulin 65 750 mg/dL
- Completed 18-20 cycles of daratumumab-lenalidomide-dexamethasone or isatuximab-lenalidomide-dexamethasone
- Achieved at least partial response per 2016 IMWG criteria
- ECOG performance status 0 to 3
- Able and willing to complete quality of life or health utility questionnaires in English, French, or provided language
- Consent obtained per local and regulatory requirements
- Accessible for treatment and follow-up
- Protocol treatment to begin within 2 working days of enrollment
- Participants of childbearing potential agree to use highly effective contraception
You will not qualify if you...
- Known history of amyloid light chain amyloidosis, POEMS syndrome, or Waldenstrom's macroglobulinemia
- Receiving other anti-cancer therapy that interferes with protocol treatment
- Active uncontrolled bacterial, fungal, or viral infection within 7 days before enrollment
- Known HIV infection with CD4 count below 350 cells/microliter
- HIV positive patients must be on antiretroviral therapy for at least 4 weeks before enrollment with acceptable drug interactions
- HIV viral load must be below 400 copies/ml within 16 weeks before enrollment
- No history of opportunistic infections within the past year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
2
BCCA - Kelowna
Kelowna, British Columbia, Canada, V1Y 5L3
Actively Recruiting
3
BCCA - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
4
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
5
The Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Actively Recruiting
6
Regional Health Authority B, Zone 2
Saint John, New Brunswick, Canada, E2L 4L2
Actively Recruiting
7
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Actively Recruiting
8
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Actively Recruiting
9
William Osler Health System
Brampton, Ontario, Canada, L6R 3J7
Actively Recruiting
10
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
11
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
12
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, Canada, N2G 1G3
Actively Recruiting
13
London Health Sciences Centre Research Inc.
London, Ontario, Canada, N6A 5W9
Actively Recruiting
14
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, Canada, L3Y 2P9
Actively Recruiting
15
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Actively Recruiting
16
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
17
Algoma District Cancer Program
Sault Ste. Marie, Ontario, Canada, P6B 0A8
Actively Recruiting
18
Niagara Health System
St. Catharines, Ontario, Canada, L2S 0A9
Actively Recruiting
19
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
20
St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
Actively Recruiting
21
Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Actively Recruiting
22
CIUSSS de l'Est-de-I'lle-de-Montreal
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
23
The Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
24
St. Mary's Hospital
Montreal, Quebec, Canada, H3T 1M5
Actively Recruiting
25
The Research Institute of the McGill University
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
26
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
27
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Actively Recruiting
28
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Actively Recruiting
Research Team
A
Annette Hay
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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