60 Participants Needed

Metformin XR for Preventing Multiple Myeloma

Recruiting at 6 trial locations
CR
Irene Ghobrial, MD profile photo
Omar Nadeem, MD profile photo
Overseen ByOmar Nadeem, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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)

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on medications for diabetes treatment.

Is Metformin XR safe for humans?

The research does not provide specific safety information about Metformin XR for preventing multiple myeloma, but Metformin (also known as Glucophage, Glucophage XR, Glumetza, Riomet, Riomet ER, Fortamet) is generally considered safe for humans and is commonly used to treat diabetes.12345

How is the drug Metformin XR unique in preventing multiple myeloma?

Metformin XR is unique in the context of multiple myeloma because it is traditionally used to manage blood sugar levels in diabetes, and its use in preventing multiple myeloma represents a novel approach that differs from the standard treatments like immunotherapy and combination drug regimens typically used for this condition.678910

What data supports the effectiveness of the drug Metformin XR for preventing multiple myeloma?

A study found that the use of metformin in US veterans with diabetes was associated with a reduced progression from a condition called monoclonal gammopathy of undetermined significance (MGUS) to multiple myeloma, suggesting potential effectiveness in prevention.13111213

Who Is on the Research Team?

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

Omar Nadeem, MD

Principal Investigator

Dana-Farber Cancer Institute

CR

Catherine R Marinac, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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
Your bilirubin levels are within the normal range for the testing lab, unless you have Gilbert's Disease, in which case your direct bilirubin levels should be within the normal range.
See 6 more

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.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Metformin or Placebo for 6 months with dose escalation

6 months
Regular visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants who received Metformin can continue for an additional 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Metformin XR
  • Placebo
Trial Overview The 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Group II: MetforminExperimental Treatment1 Intervention

Metformin XR is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Glucophage for:
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Approved in European Union as Glucophage for:
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Approved in Canada as Glumetza for:
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Approved in Japan as Riomet for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

The introduction of novel agents for treating relapsed and/or refractory multiple myeloma (RRMM) has significantly improved response rates, rising from about 30% with single agents to up to 90% with combination therapies.
Newer treatments, including pomalidomide, panobinostat, carfilzomib, ixazomib, and monoclonal antibodies like daratumumab and elotuzumab, have enhanced overall response rates, even in heavily pretreated patients, while also improving the tolerability of treatment regimens and health-related quality of life.
How have evolutions in strategies for the treatment of relapsed/refractory multiple myeloma translated into improved outcomes for patients?Sonneveld, P., De Wit, E., Moreau, P.[2022]
In a real-world study of 47 patients with relapsed/refractory multiple myeloma treated with daratumumab, bortezomib, and dexamethasone (DVd), the overall response rate was 78%, indicating that this combination is an effective treatment option.
The treatment was found to be safe, with mostly mild adverse events and no cases leading to permanent drug interruptions, and the median progression-free survival was 10 months, suggesting good durability of response.
Real-world effectiveness and safety of daratumumab, bortezomib and dexamethasone in relapsed/refractory multiple myeloma in Slovakia.Harvanová, Ľ., Štulajterová, V., Guman, T., et al.[2021]
In a study of 138 Korean patients with relapsed/refractory multiple myeloma, carfilzomib combined with lenalidomide and dexamethasone (KRd) was associated with a higher risk of specific adverse events, including dyspnea, muscle spasms, and thrombocytopenia, particularly during the early treatment cycles.
Despite the increased risk of these side effects, most adverse events were of low severity (grade 1-2), suggesting that while carfilzomib has notable side effects, it can still be used effectively and safely in real-world treatment settings for RRMM.
Carfilzomib's Real-World Safety Outcomes in Korea: Target Trial Emulation Study Using Electronic Health Records.Jang, HY., Lee, HK., Kim, CJ., et al.[2023]

Citations

How have evolutions in strategies for the treatment of relapsed/refractory multiple myeloma translated into improved outcomes for patients? [2022]
Association between metformin use and progression of monoclonal gammopathy of undetermined significance to multiple myeloma in US veterans with diabetes mellitus: a population-based retrospective cohort study. [2022]
Daratumumab, Cyclophosphamide, Bortezomib, Lenalidomide, and Dexamethasone as Induction and Extended Consolidation Improves Outcome in Ultra-High-Risk Multiple Myeloma. [2023]
Pre-existing diabetes mellitus in patients with multiple myeloma. [2012]
Real-world effectiveness and safety of daratumumab, bortezomib and dexamethasone in relapsed/refractory multiple myeloma in Slovakia. [2021]
Carfilzomib's Real-World Safety Outcomes in Korea: Target Trial Emulation Study Using Electronic Health Records. [2023]
A comparison of the efficacy and safety of ixazomib and lenalidomide combined with dexamethasone in the treatment of multiple myeloma. [2021]
Investigating the Vascular Toxicity Outcomes of the Irreversible Proteasome Inhibitor Carfilzomib. [2021]
Multiple Myeloma: Clinical Updates From the American Society of Hematology Annual Meeting 2018. [2020]
Therapeutic Monoclonal Antibodies and Antibody Products: Current Practices and Development in Multiple Myeloma. [2020]
Novel investigational drugs active as single agents in multiple myeloma. [2017]
An update on the use of lenalidomide for the treatment of multiple myeloma. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Daratumumab Plus Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma. [2022]
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