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

Last updated: April 13, 2026
Sponsor: Canadian Cancer Trials Group
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoproliferative Disorders

Multiple Myeloma

Bone Neoplasm

Treatment

Isatuximab

Lenalidomide

Dexamethasone

Clinical Study ID

NCT06182774
MY13
  • Ages > 18
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with newly diagnosed multiple myeloma that are transplant-ineligible

  • Measurable disease at the time of diagnosis, as defined by at least one of thefollowing 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, providedserum FLC ration is abnormal; For IgA patients whose disease can only be reliablymeasured by serum quantitative immunoglobulin ≥ 750 mg/dL

  • Completed 18-20 cycles of daratumumab-lenalidomide-dexamethasone orisatuximab-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 qualityof life and/or health utility questionnaires in English, French, or a providedvalidated language.

  • Participant consent must be appropriately obtained in accordance with applicablelocal 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 daysof participant enrollment.

  • Participants of childbearing potential must have agreed to use a highly effectivecontraceptive method.

Exclusion

Exclusion Criteria:

  • Known history of concurrent amyloid light chain amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skinchanges), and Waldenstrom's macroglobulinemia.

  • Patients receiving concurrent treatment with other anti-cancer therapy that wouldimpact the ability to comply with protocol treatment are ineligible. Note:Participants with a prior or concurrent malignancy whose natural history ortreatment does not have the potential to interfere with the safety or efficacyassessment of protocol treatment are eligible for this trial

  • Active, uncontrolled bacterial, fungal, or viral infection within 7 days prior toenrollment.

  • Known human immunodeficiency virus (HIV) with CD4 count < 350 cells/microliter. Notethat patients who are HIV positive are eligible, provided:

  • They are under treatment with antiretroviral therapy for at least 4 weeks priorto enrollment, with acceptable pharmacokinetic interactions and minimaloverlapping 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.

Study Design

Total Participants: 570
Treatment Group(s): 4
Primary Treatment: Isatuximab
Phase: 3
Study Start date:
April 10, 2024
Estimated Completion Date:
July 31, 2032

Study 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.

Connect with a study center

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • BCCA - Kelowna

    Kelowna, British Columbia V1Y 5L3
    Canada

    Active - Recruiting

  • BCCA - Vancouver

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • BCCA - Kelowna

    Kelowna 5990579, British Columbia 5909050 V1Y 5L3
    Canada

    Site Not Available

  • BCCA - Vancouver

    Vancouver 6173331, British Columbia 5909050 V5Z 4E6
    Canada

    Site Not Available

  • CancerCare Manitoba

    Winnipeg, Manitoba R3E 0V9
    Canada

    Active - Recruiting

  • CancerCare Manitoba

    Winnipeg 6183235, Manitoba 6065171 R3E 0V9
    Canada

    Site Not Available

  • The Moncton Hospital

    Moncton, New Brunswick E1C 6Z8
    Canada

    Active - Recruiting

  • Regional Health Authority B, Zone 2

    Saint John, New Brunswick E2L 4L2
    Canada

    Active - Recruiting

  • The Moncton Hospital

    Moncton 6076211, New Brunswick 6087430 E1C 6Z8
    Canada

    Site Not Available

  • Regional Health Authority B, Zone 2

    Saint John 6138517, New Brunswick 6087430 E2L 4L2
    Canada

    Site Not Available

  • Dr. H. Bliss Murphy Cancer Centre

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

    Active - Recruiting

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's 6324733, Newfoundland and Labrador 6354959 A1B 3V6
    Canada

    Site Not Available

  • Royal Victoria Regional Health Centre

    Barrie, Ontario L4M 6M2
    Canada

    Active - Recruiting

  • William Osler Health System

    Brampton, Ontario L6R 3J7
    Canada

    Active - Recruiting

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario L8V 5C2
    Canada

    Active - Recruiting

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • Grand River Regional Cancer Centre

    Kitchener, Ontario N2G 1G3
    Canada

    Active - Recruiting

  • Waterloo Regional Health Network (WRHN)

    Kitchener, Ontario N2G 1G3
    Canada

    Active - Recruiting

  • London Health Sciences Centre Research Inc.

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Verspeeten Family Cancer Centre

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario L3Y 2P9
    Canada

    Active - Recruiting

  • Lakeridge Health Oshawa

    Oshawa, Ontario L1G 2B9
    Canada

    Active - Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Algoma District Cancer Program

    Sault Ste. Marie, Ontario P6B 0A8
    Canada

    Active - Recruiting

  • Niagara Health System

    St. Catharines, Ontario L2S 0A9
    Canada

    Active - Recruiting

  • St. Joseph's Health Centre

    Toronto, Ontario M6R 1B5
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Windsor Regional Cancer Centre

    Windsor, Ontario N8W 2X3
    Canada

    Active - Recruiting

  • Royal Victoria Regional Health Centre

    Barrie 5894171, Ontario 6093943 L4M 6M2
    Canada

    Site Not Available

  • William Osler Health System

    Brampton 5907364, Ontario 6093943 L6R 3J7
    Canada

    Site Not Available

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton 5969782, Ontario 6093943 L8V 5C2
    Canada

    Site Not Available

  • Kingston Health Sciences Centre

    Kingston 5992500, Ontario 6093943 K7L 2V7
    Canada

    Site Not Available

  • Waterloo Regional Health Network (WRHN)

    Kitchener 5992996, Ontario 6093943 N2G 1G3
    Canada

    Site Not Available

  • London Health Sciences Centre Research Inc.

    London 6058560, Ontario 6093943 N6A 5W9
    Canada

    Site Not Available

  • Stronach Regional Health Centre at Southlake

    Newmarket 6087701, Ontario 6093943 L3Y 2P9
    Canada

    Site Not Available

  • Lakeridge Health Oshawa

    Oshawa 6094578, Ontario 6093943 L1G 2B9
    Canada

    Site Not Available

  • Ottawa Hospital Research Institute

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Site Not Available

  • Algoma District Cancer Program

    Sault Ste. Marie 6141439, Ontario 6093943 P6B 0A8
    Canada

    Site Not Available

  • Niagara Health System

    St. Catharines 6155721, Ontario 6093943 L2S 0A9
    Canada

    Site Not Available

  • St. Joseph's Health Centre

    Toronto 6167865, Ontario 6093943 M6R 1B5
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto 6167865, Ontario 6093943 M5B 1W8
    Canada

    Site Not Available

  • Windsor Regional Cancer Centre

    Windsor 6182962, Ontario 6093943 N8W 2X3
    Canada

    Site Not Available

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

    Montreal, Quebec H1T 2M4
    Canada

    Active - Recruiting

  • St. Mary's Hospital

    Montreal, Quebec H3T 1M5
    Canada

    Site Not Available

  • The Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • The Research Institute of the McGill University

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

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

    Quebec City, Quebec G1J 1Z4
    Canada

    Site Not Available

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

    Québec, Quebec G1J 1Z4
    Canada

    Active - Recruiting

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

    Montreal 6077243, Quebec 6115047 H1T 2M4
    Canada

    Active - Recruiting

  • The Jewish General Hospital

    Montreal 6077243, Quebec 6115047 H3T 1E2
    Canada

    Site Not Available

  • The Research Institute of the McGill University

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Active - Recruiting

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

    Québec 6325494, Quebec 6115047 G1J 1Z4
    Canada

    Site Not Available

  • Allan Blair Cancer Centre

    Regina, Saskatchewan S4T 7T1
    Canada

    Active - Recruiting

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan S7N 4H4
    Canada

    Active - Recruiting

  • Allan Blair Cancer Centre

    Regina 6119109, Saskatchewan 6141242 S4T 7T1
    Canada

    Site Not Available

  • Saskatoon Cancer Centre

    Saskatoon 6141256, Saskatchewan 6141242 S7N 4H4
    Canada

    Site Not Available

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