Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma (NCT03346135) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma
United States31 participantsStarted 2019-07-17
Plain-language summary
This phase II trial studies how well daratumumab after a stem cell transplant works in treating patients with multiple myeloma. Monoclonal antibodies, such as daratumumab, may kill cancer cells that are left after chemotherapy.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All subjects must have the ability to understand and the willingness to sign a written informed consent
* Histologically confirmed diagnosis of multiple myeloma; (patients with multiple myeloma with secondary amyloidosis are eligible)
* Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-13 months of the first dose of initial therapy
* Eastern Cooperative Oncology Group (ECOG) =\< 2
* Patients with planned standard of care ASCT using melphalan 200 mg/m\^2; dose modifications in accordance with creatinine clearance levels are allowed per physician judgment
* Adequate organ function for high dose chemotherapy and autologous stem cell transplant (as per institution standard operating procedure \[SOP\])
* Adequate cell dose \> 2.5 x 10\^6 CD34+ cells/kg
* Absolute neutrophil count (ANC) \>= 1000/mm\^3
* Platelet count \>= 75,000/mm\^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days before study enrollment
* Total bilirubin =\< 1.5 x the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) =\< 3 x ULN
* Alanine aminotransferase (ALT) =\< 3 x ULN
* Calculated creatinine clearance \>= 30 mL/min
* Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, inje…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival
Timeframe: From date of first dose of study drug to first documented date of disease relapse, progression, or death (from any cause), whichever occurs first, assessed for up to 18 months after last dose of study drug