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TERMINATED
NCT02967276
PHASE2

Clinical Activity of Metformin With High-dose of Dexamethasone in Relapse Multiple Myeloma

Sponsor: University of Campinas, Brazil

View on ClinicalTrials.gov

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.

Official title: Phase II Trial, Open Label, Clinical Activity of Metformin in Combination With High-dose of Dexamethasone (HDdexa) in Patients With Relapsed/Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2017-01

Completion Date

2020-02

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DRUG

Metformin XR

500 mg tablet: They take 1-5 tablets of 500 mg after dinner. Starting dose of Metformin XR 500 mg. It will have an increase of 500 mg/day each week up to the maximum tolerance from the 2500 mg / day, during the 6 cycles.

DRUG

Dexamethasone

4 mg tablet: Patients will use 40 mg per day. They take 5-10 tablets 4mg after breakfast and lunch. Patients over age 75 will use 20 mg / day.

Locations (2)

UOPECCAN - Hospital do Câncer de Cascavel

Cascavel, Paraná, Brazil

Hemocentro - Hospital de Clínicas - State University of Campinas (UNICAMP)

Campinas, São Paulo, Brazil