Trial comparing treatments 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, 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
- This study is testing whether a fixed‑duration anti‑CD38 antibody treatment works as well as continuous treatment.
- Who it's for
- You may be able to join if you are an older adult with newly diagnosed multiple myeloma who cannot have a transplant.
- What's involved
- You would receive daratumumab or isatuximab together with lenalidomide and dexamethasone. You might stop the antibody after about 18 months or keep taking it, and you will have regular doctor visits and tests.
- Time commitment
- The study lasts about two years with several scheduled visits and check‑ins.
- 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.
- 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
- No history of opportunistic infections within the past year.
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
- 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.
- 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 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 is enrolling
- 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
- Mississauga, Ontario, Canada
- Newmarket, Ontario, Canada
- Oakville, Ontario, Canada
- Oshawa, Ontario, Canada
- Ottawa, Ontario, Canada
- Sault Ste. Marie, Ontario, Canada
- St. Catharines, Ontario, Canada
+ 7 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, but 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?
This study is enrolling now at Edmonton, Alberta, Canada; Kelowna, British Columbia, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Moncton, New Brunswick, Canada; Saint John, New Brunswick, Canada and 21 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.