Comparing Lenalidomide with Daratumumab for multiple myeloma
Official title: 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
- Phase 3
- 2 groups
- Sites in Edmonton, Kelowna and 22 more cities
- Recruiting
Interventions (4)
- Medication
Daratumumab
Dose determined at enrollment
- Medication
Lenalidomide
Dose determined at enrollment
- Medication
Dexamethasone
Dose determined at enrollment
- Medication
Isatuximab
Dose determined at enrollment
Canadian Sites (28)
28 of 28 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta
- Recruiting
BCCA - Kelowna
Kelowna, British Columbia
- Recruiting
BCCA - Vancouver
Vancouver, British Columbia
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba
- Recruiting
The Moncton Hospital
Moncton, New Brunswick
- Recruiting
Regional Health Authority B, Zone 2
Saint John, New Brunswick
- Recruiting
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario
- Recruiting
William Osler Health System
Brampton, Ontario
- Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario
- Recruiting
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario
- Recruiting
London Health Sciences Centre Research Inc.
London, Ontario
- Recruiting
Stronach Regional Health Centre at Southlake
Newmarket, Ontario
- Recruiting
Lakeridge Health Oshawa
Oshawa, Ontario
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario
- Recruiting
Algoma District Cancer Program
Sault Ste. Marie, Ontario
- Recruiting
Niagara Health System
St. Catharines, Ontario
- Recruiting
St. Michael's Hospital
Toronto, Ontario
- Recruiting
St. Joseph's Health Centre
Toronto, Ontario
- Recruiting
Windsor Regional Cancer Centre
Windsor, Ontario
- Recruiting
CIUSSS de l'Est-de-I'lle-de-Montreal
Montreal, Quebec
- Recruiting
The Jewish General Hospital
Montreal, Quebec
- Recruiting
St. Mary's Hospital
Montreal, Quebec
- Recruiting
The Research Institute of the McGill University
Montreal, Quebec
- Recruiting
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
Québec, Quebec
- Recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Completed 18-20 cycles of daratumumab-lenalidomide-dexamethasone or isatuximab-lenalidomide-dexamethasone.
- +Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
- +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
- +Obtained at least a partial response per the standard 2016 IMWG criteria
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → must be appropriately obtained in accordance with applicable local and regulatory requirements.
- +Participants must be accessible for treatment and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
- +In accordance with CCTG policy, protocolProtocolThe detailed plan a study must follow.Read more → treatment is to begin within 2 working days of participant enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- +ECOG performance status 0-3
Exclusion
- −Known human immunodeficiency virus (HIV) with CD4 count \< 350 cells/microliter. Note that patients who are HIV positive are eligible, provided:
- −HIV viral load must be \< 400 copies/ml within 16 weeks prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → AND
- −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 protocolProtocolThe detailed plan a study must follow.Read more → 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.
- −They are under treatment with antiretroviral therapy for at least 4 weeks prior to enrollment, with acceptable pharmacokineticPharmacokineticsThe study of how the body absorbs, distributes, and clears a treatment.Read more → interactions and minimal overlapping toxicity with protocol therapy AND
- −No history of opportunistic infections within the past year.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Lenalidomide and Dexamethasone.
Registry label: A: Lenalidomide & Dexamethasone
Group B, the comparison group, receives Daratumumab, Lenalidomide, Dexamethasone and Isatuximab.
Registry label: B: Daratumumab, Lenalidomide, Dexamethasone & Isatuximab
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 570 people.
The study is currently expected to finish around July 2032.
The main measurement is taken over: 9.1 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-Free Survival — measured over 9.1 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06182774 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About DaratumumabDrug
Dose determined at enrollment
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LenalidomideDrug
Dose determined at enrollment
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About DexamethasoneDrug
Dose determined at enrollment
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About IsatuximabDrug
Dose determined at enrollment
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 9.1 years.
The study as a whole is currently expected to finish around 2032-07-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 570 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 24 locations, including: Edmonton, Alberta, Canada; Kelowna, British Columbia, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Moncton, New Brunswick, Canada; Saint John, New Brunswick, Canada, and 18 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.