Metformin XR for Preventing Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+6 other locations

Omar Nadeem, MD - Dana-Farber Cancer ...

Overseen byOmar Nadeem, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this research is to understand whether the drug metformin could be used in the future to help prevent patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) from developing multiple myeloma. The names of the study drug involved in this study is: * Metformin, extended release * Placebo ( a pill that has no active ingredients)

Research Team

Omar Nadeem, MD

Principal Investigator

Dana-Farber Cancer Institute

Catherine R Marinac, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with higher-risk MGUS or low-risk SMM, who can consent to the study. They must have good organ function and not meet criteria for active multiple myeloma. Pregnant women, those on diabetes meds, heavy drinkers, or anyone with conditions affecting drug absorption or increasing risk of lactic acidosis cannot join.

Inclusion Criteria

Your AST and ALT levels must be less than 1.5 times the normal limit at the institution where you are being treated.

Ability to understand and the willingness to sign a written informed consent document

I am 18 years old or older.

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Exclusion Criteria

Any other condition that, in the investigator's judgment, would contraindicate the use of metformin or otherwise interfere with participation in the trial

I am taking medication for diabetes.

I don't have conditions that increase the risk of lactic acidosis and I drink less than 3 alcoholic drinks a day.

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Treatment Details

Interventions

Metformin XR (Biguanide)
Placebo (Other)

Trial OverviewThe study is testing if Metformin XR can prevent progression from precursor stages (MGUS/SMM) to full-blown Multiple Myeloma compared to a placebo. Participants will be randomly assigned to receive either Metformin XR or a placebo pill without any active ingredients.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Randomly assigned participants receive a stepped dose escalation until target daily dose of 3 pills/day is reached. The intervention duration will last 6 months.

Group II: MetforminExperimental Treatment1 Intervention

Randomly assigned participants receive a stepped dose escalation until target daily dose of 1500mg Metformin XR is reached (3 x 500mg pills/day). The intervention duration will last an additional 6 months. Metformin Extension: Participants will have the option of unblinding at the end of their 6months treatment and those who were randomly assigned to the metformin experimental arm can continue taking metformin if they opt in. The extended intervention duration will last an additional 6 months. (1500mg Metformin XR or highest tolerated dose )

Metformin XR is already approved in Canada, Japan for the following indications: