Diabetes drug metformin could boost myeloma treatment
NCT ID NCT02967276
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This phase 2 trial tests whether adding metformin — a common diabetes medication — to high-dose dexamethasone can improve outcomes for people with multiple myeloma that has returned or stopped responding to prior treatments. The study enrolls adults over 18 who have failed at least two previous lines of therapy. Participants take metformin daily along with high-dose dexamethasone for six cycles, and researchers measure how many patients achieve a complete, partial, or minimal response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metformin and dexamethasone
- What this could lead to
- If it works, this could offer a new, affordable treatment option for patients with multiple myeloma that has stopped responding to standard therapies.
- What could go wrong
- This is a small, early-phase trial (28 people) with no placebo group, so results may not be definitive. Metformin can cause gastrointestinal side effects, and high-dose dexamethasone has significant risks like infection and high blood sugar.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
28 people
The number who actually took part.
- Started
-
Jan 2017
- Finished
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Feb 2020
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 Hide 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: * 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), hepatitis B virus (HBV) or hepatitis C virus (HCV) (wif the exception treated or cured chronic HBV and HCV infection, who will be allowed); * Patients who are using another study medication or who has received drug under study for less TEMPthan 4 weeks; * It is allowed concomitant treatment wif bisphosphonates; however, treatment should be started before the first dose of study therapy; . It is not allowed to use of all herbal supplements during the study (including, but not limited to, St. John's wort, kava, None, gingko biloba, dehydroepiandrosterone \[DHEA\], or ginseng). Megestrol acetate (Megace) or medroxyprogesterone if used as an appetite stimulant is permitted; * Uncontrolled situations by intercurrent disease, including, but not limited to, infection ongoing and active, refractory systemic hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric / social disease that would limit compliance wif the requirements of study; * Previous Neoplasms, except skin cancer for over two years; * Patients who are pregnant or breastfeeding. * Any major surgery, extensive radiation therapy, chemotherapy delayed toxicity, biological therapy, chemotherapy or immunotherapy wifin 28 days before study.
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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.
Contacts and locations
Locations
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Hemocentro - Hospital de Clínicas - State University of Campinas (UNICAMP)
Campinas, São Paulo, Brazil
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UOPECCAN - Hospital do Câncer de Cascavel
Cascavel, Paraná, Brazil
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