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Could less be more? major trial tests shorter drug regimen for myeloma

NCT ID NCT06182774

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This study is for older adults with newly diagnosed multiple myeloma who cannot have a stem cell transplant. It compares taking the drugs daratumumab or isatuximab continuously versus stopping after about a year and a half, while continuing other medications. The goal is to see if the shorter treatment works just as well to control the disease and has fewer side effects. About 570 participants will be enrolled.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 570 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jul 2032

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Algoma District Cancer Program

    RECRUITING

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

  • Allan Blair Cancer Centre

    RECRUITING

    Regina, Saskatchewan, S4T 7T1, Canada

  • BCCA - Kelowna

    RECRUITING

    Kelowna, British Columbia, V1Y 5L3, Canada

  • BCCA - Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

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

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

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

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • CancerCare Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dr. H. Bliss Murphy Cancer Centre

    RECRUITING

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

  • Juravinski Cancer Centre at Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Kingston Health Sciences Centre

    RECRUITING

    Kingston, Ontario, K7L 2V7, Canada

  • Lakeridge Health Oshawa

    RECRUITING

    Oshawa, Ontario, L1G 2B9, Canada

  • London Health Sciences Centre Research Inc.

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Niagara Health System

    RECRUITING

    St. Catharines, Ontario, L2S 0A9, Canada

  • Ottawa Hospital Research Institute

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • Regional Health Authority B, Zone 2

    RECRUITING

    Saint John, New Brunswick, E2L 4L2, Canada

  • Royal Victoria Regional Health Centre

    RECRUITING

    Barrie, Ontario, L4M 6M2, Canada

  • Saskatoon Cancer Centre

    RECRUITING

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • St. Joseph's Health Centre

    RECRUITING

    Toronto, Ontario, M6R 1B5, Canada

  • St. Mary's Hospital

    RECRUITING

    Montreal, Quebec, H3T 1M5, Canada

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • Stronach Regional Health Centre at Southlake

    RECRUITING

    Newmarket, Ontario, L3Y 2P9, Canada

  • The Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • The Moncton Hospital

    RECRUITING

    Moncton, New Brunswick, E1C 6Z8, Canada

  • The Research Institute of the McGill University

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Thunder Bay Regional Health Sciences Centre/

    RECRUITING

    Thunder Bay, Ontario, P7B 6V4, Canada

  • Waterloo Regional Health Network (WRHN)

    RECRUITING

    Kitchener, Ontario, N2G 1G3, Canada

  • William Osler Health System

    RECRUITING

    Brampton, Ontario, L6R 3J7, Canada

  • Windsor Regional Cancer Centre

    RECRUITING

    Windsor, Ontario, N8W 2X3, Canada

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Other studies related to the condition(s) this trial covers.