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Multiple MyelomaPhase 3NCT06182774

Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma

A Phase 3 study testing Daratumumab, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Canadian Cancer Trials Group at 31 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Daratumumab, Lenalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
570 participants
Where
31 sitesCanada
Study dates
10 Apr 2024to 31 Jul 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

31 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Annette Hay contact

613-533-6430

ahay@ctg.queensu.ca

31 sites in 1 country

Canada31 sites, 31 recruiting

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

    Rouslan Kotchetkov

    Recruiting

  • William Osler Health System

    Brampton, Ontario, L6R 3J7

    Savannah Norman, 416 494-2120

    Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Steven Shih

    Recruiting

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

    Hira Mian, 905 387-9495

    Recruiting

  • BCCA - Kelowna

    Kelowna, British Columbia, V1Y 5L3

    Erma Gardner, 250 712-3900

    Recruiting

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

    Bethany Monteith

    Recruiting

  • Waterloo Regional Health Network (WRHN)

    Kitchener, Ontario, N2G 1G3

    Armela Dicu, 519 749-4370

    Recruiting

  • London Health Sciences Centre Research Inc.

    London, Ontario, N6A 5W9

    Martha Louzada, 519 685-2391

    Recruiting

  • Trillium Health Partners - Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

    Farheen Manji

    Recruiting

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

    Nizar Abdel-Samad, 506 870-2404

    Recruiting

  • CIUSSS de l'Est-de-I'lle-de-Montreal

    Montreal, Quebec, H1T 2M4

    Richard LeBlanc, 514 252-3400 ext. 3404

    Recruiting

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Rayan Kaedbey, 614 340-8222

    Recruiting

  • St. Mary's Hospital

    Montreal, Quebec, H3T 1M5

    Tanya Skamene, 514 340-8222

    Recruiting

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1

    Michael Sebag, 514 398-8307

    Recruiting

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

    Peter James Anglin, 905 895-4521

    Recruiting

  • Oakville Trafalgar Memorial Hospital

    Oakville, Ontario, L6M 0L8

    Adam Suleman

    Recruiting

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

    Ariah Joshua Schattner, 905 576-8711

    Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

    Arleigh B. Robertson McCurdy, 613 737-7700

    Recruiting

  • CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)

    Québec, Quebec, G1J 1Z4

    Julie Cote, 418 525-4444 ext. 63115

    Recruiting

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

    Ibraheem Mohammed Othman, 306 766-2691

    Recruiting

  • Regional Health Authority B, Zone 2

    Saint John, New Brunswick, E2L 4L2

    Anthony J. Reiman, 506 648-6884

    Recruiting

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

    Julie Stakiw, 306 655-2980

    Recruiting

  • Algoma District Cancer Program

    Sault Ste. Marie, Ontario, P6B 0A8

    Danny Hill, 705 759-3434 ext. 4450

    Recruiting

  • Niagara Health System

    St. Catharines, Ontario, L2S 0A9

    Huma Qawi, 905 684-7271 ext. 43801

    Recruiting

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

    Debra Bergstrom, 709 777-7557

    Recruiting

  • Thunder Bay Regional Health Sciences Centre/

    Thunder Bay, Ontario, P7B 6V4

    Nicole Laferriere, 807 684-7200

    Recruiting

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

    Martina Trinkaus, 416 864-5632

    Recruiting

  • St. Joseph's Health Centre

    Toronto, Ontario, M6R 1B5

    Christie Kim

    Recruiting

  • BCCA - Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Christopher Venner

    Recruiting

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

    Sindu Mary Kanjeekal, 519 253-5253 ext. 58616

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Rami R. Kotb, 204 787-2108

    Recruiting

Other trials in Canada

About this study

Official title: 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

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?

Read the detailed description

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.

Being tested
Daratumumab, Lenalidomide, Dexamethasone, Isatuximab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06182774
Study groupRoleWhat they receive
Lenalidomide & DexamethasoneExperimentalNot described
Receives: Drug: Lenalidomide; Drug: Dexamethasone
Daratumumab, Lenalidomide, Dexamethasone & IsatuximabActive comparatorStandard of Care
Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Isatuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival

    PFS is defined as the time from date of enrollment to date of first documentation of disease progression

    Measured: 9.1 years

Secondary outcomes (8)

  1. Overall Survival

    Time from enrollment to death from any cause

    Measured: 9.1 years

  2. Partial Response or Better as assessed by IMWG Criteria

    Measured: 9.1 years

  3. Incidence of Treatment-Related Grade 3-5 Adverse Events and all infections based on CTCAE 5.0

    Measured: 9.1 years

  4. Time to Next Treatment

    Time from enrollment to the start of next-line treatment

    Measured: 9.1 years

  5. Post-protocol Therapy Documentation checklist

    Documentation of patients 2nd line treatment after treatment completion of daratumumab, or isatuximab, lenalidomide, and dexamethasone

    Measured: 9.1 years

  6. Quality of Life Utilizing EORTC QLQ-C30

    Measured: 9.1 years

  7. Quality of Life Utilizing FACIT-COST

    Measured: 9.1 years

  8. 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

    Measured: 9.1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2023
  2. Study start10 Apr 2024
  3. Primary completion31 Jan 2032 (estimated)
  4. Study completion31 Jul 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
570 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06182774
Sponsor's protocol ID
MY13
Status last verified
Jan 2026
First submitted
13 Dec 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daratumumab, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Canadian Cancer Trials Group at 31 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Annette Hay (613-533-6430, ahay@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: 9.1 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06182774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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Clinical Trial NCT06182774 | AzTrials