Clinical Activity of Metformin With High-dose of Dexamethasone in Relapse Multiple Myeloma (NCT02967276) | Clinical Trial Compass
TerminatedPhase 2
Clinical Activity of Metformin With High-dose of Dexamethasone in Relapse Multiple Myeloma
Stopped: Recruitment difficulties due to more attractive competing studies.
Brazil28 participantsStarted 2017-01
Plain-language summary
This phase II trial study assessing the activity of metformin when given together with high dose of dexamethasone in treating patients with multiple myeloma (MM) that has relapse or refractory to previous treatment. High dose of dexamethasone (HDdexa) is used to treat relapse/refractary patients with myeloma and metformin also demonstrated synergistic activity with dexamethasone to eradicate MM cells in vitro and in vivo. Metformin hydrochloride, used for diabetes, may also help kill tumor cells. Giving dexamethasone with metformin may kill more MM cells and increase the response rate to HDdexa.
Who can participate
Age range
18 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:
* Patients over 18 years;
* Multiple myeloma patients relapsed or refractory to two lines prior to treatment \[at least one line using bortezomib or prior treatment wif a suitable alkylating agent (at least six cycles of treatment wif alkylating or progressive disease after at least two cycles of treatment wif alkylating or treatment wif alkylating received as part of a stem cell transplant)\];
* Patients should of failed (progressive disease at or before 60 days of treatment, disease progression ≤6 months after achieving partial response or intolerance to bortezomib) to treatment wif bortezomib;
* Patients wif oral access to medicines;
* ECOG ≤ 2;
* Blood count: hemoglobin ≥8 g / dL; absolute neutrophil count ≥500 / mm3 and platelet count ≥30.000 / mm3; glomerular filtration rate (GFR) ≥ 30ml / min and adequate liver function (AST or ALT at levels 3x upper limit of normal; bilirubin in levels no greater TEMPthan 2x the upper limit of normal; negative pregnancy test before study initiation or accept contraceptive use.
Exclusion Criteria:
* Patients wif non hypersensitivity and / or prior therapy wif metformin or its excipients;
* Diabetes mellitus who require insulin use and other oral hypoglycemic agents; patients wif a history of hyperglycemia induced by steroids can be entered since HbA1C in screening visit is \<8%;
* leptomeningeal or brain metastases symptomatic or untreated, or spinal cord compression;
* Known human immunodeficiency virus (HIV), h…
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.
1This trial was terminated before completing — do you know why it was stopped, and does that affect whether the metformin plus high-dose dexamethasone combination is still considered a viable option for my relapsed myeloma?
2Since this was a Phase 2 trial that didn't finish, the safety and effectiveness data may be incomplete — what do we actually know so far about how well this combination worked and what side effects patients experienced?
3High-dose dexamethasone can have serious side effects on its own, and I also have relapsed myeloma — how would adding metformin change the risk profile compared to other treatment options you'd recommend for me at this stage?
4Given that this trial was terminated and may not have reached its goal of measuring response rate, are there other active or completed trials — or standard-of-care regimens — that would be a stronger option to consider right now?
5Metformin is a diabetes medication being tested here for myeloma — what is the scientific rationale behind using it for relapsed multiple myeloma, and is there enough evidence from this or other studies to justify it as part of my treatment plan?
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
Response Rate (RR)
Timeframe: From the date of randomization to the date of the first major documented response (CR, PR or MR) that occurs, evaluated up to 35 days after the completion of 6th treatment cycles or if the response occurs earlier.