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Compares treatment options for Multiple Myeloma
Official title Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma
ClinicalTrials.gov ID: NCT06182774
What this study is testing
What is Daratumumab?
Daratumumab is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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
You likely can't join if
- Known history of concurrent amyloid light chain amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and...
- Patients receiving concurrent treatment with other anti-cancer therapy that would impact the ability to comply with protocol treatment are...
- 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...
- HIV viral load must be \< 400 copies/ml within 16 weeks prior to enrollment AND
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Kelowna, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Winnipeg, Manitoba, Canada
- Moncton, New Brunswick, Canada
- Saint John, New Brunswick, Canada
- St. John's, Newfoundland and Labrador, Canada
- Barrie, Ontario, Canada
- Brampton, Ontario, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- Kitchener, Ontario, Canada
- London, Ontario, Canada
- Newmarket, Ontario, Canada
- Oshawa, Ontario, Canada
- Ottawa, Ontario, Canada
- Sault Ste. Marie, Ontario, Canada
- St. Catharines, Ontario, Canada
- Toronto, Ontario, Canada
- Windsor, Ontario, Canada
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.