Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma
A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration Versus Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma
1 other identifier
interventional
570
1 country
28
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 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Apr 2024
Typical duration for phase_3 multiple-myeloma
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2023
CompletedFirst Posted
Study publicly available on registry
December 27, 2023
CompletedStudy Start
First participant enrolled
April 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2032
April 14, 2026
January 1, 2026
7.8 years
December 13, 2023
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival
PFS is defined as the time from date of enrollment to date of first documentation of disease progression
9.1 years
Secondary Outcomes (8)
Overall Survival
9.1 years
Partial Response or Better as assessed by IMWG Criteria
9.1 years
Incidence of Treatment-Related Grade 3-5 Adverse Events and all infections based on CTCAE 5.0
9.1 years
Time to Next Treatment
9.1 years
Post-protocol Therapy Documentation checklist
9.1 years
- +3 more secondary outcomes
Study Arms (2)
Lenalidomide & Dexamethasone
EXPERIMENTALDaratumumab, Lenalidomide, Dexamethasone & Isatuximab
ACTIVE COMPARATORStandard of Care
Interventions
Dose determined at enrollment
Dose determined at enrollment
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Myeloma Canadacollaborator
- Canadian Cancer Trials Grouplead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (28)
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BCCA - Kelowna
Kelowna, British Columbia, V1Y 5L3, Canada
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
Regional Health Authority B, Zone 2
Saint John, New Brunswick, E2L 4L2, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
William Osler Health System
Brampton, Ontario, L6R 3J7, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, N2G 1G3, Canada
London Health Sciences Centre Research Inc.
London, Ontario, N6A 5W9, Canada
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, L3Y 2P9, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Algoma District Cancer Program
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Niagara Health System
St. Catharines, Ontario, L2S 0A9, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
St. Joseph's Health Centre
Toronto, Ontario, M6R 1B5, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
CIUSSS de l'Est-de-I'lle-de-Montreal
Montreal, Quebec, H1T 2M4, Canada
The Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
St. Mary's Hospital
Montreal, Quebec, H3T 1M5, Canada
The Research Institute of the McGill University
Montreal, Quebec, H4A 3J1, Canada
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
Québec, Quebec, G1J 1Z4, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hira Mian
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2023
First Posted
December 27, 2023
Study Start
April 10, 2024
Primary Completion (Estimated)
January 31, 2032
Study Completion (Estimated)
July 31, 2032
Last Updated
April 14, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share