Study on Metformin for Preventing Progression of Early-Stage Multiple Myeloma
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT04850846
This clinical trial is exploring whether the drug metformin can help prevent the progression of early-stage multiple myeloma in patients with certain precursor conditions. Participants will receive either metformin or a placebo to evaluate its effectiveness.
Patient Parameters
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Program Overview
The aim of this study is to determine if metformin, a drug commonly used to manage diabetes, can help prevent the progression of early-stage multiple myeloma in patients with conditions like monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). Metformin is being tested to see if it can slow down the disease in patients who do not yet require treatment for active multiple myeloma. Participants will be randomly assigned to receive either metformin or a placebo for six months, with the option to continue metformin for another six months if they initially received it. The study involves regular check-ups and evaluations to monitor health and treatment effects.
Description
This study is a Phase 2 trial where participants with higher-risk MGUS or low-risk SMM will receive either metformin or a placebo to see if metformin can slow down the progression of these conditions. Metformin is not yet approved for cancer prevention but is being tested because it may help prevent the progression of MGUS and SMM to active multiple myeloma. Participants will be randomly assigned to take either metformin or a placebo for six months. After this period, those who received metformin can choose to continue for another six months. The study will involve regular health evaluations and follow-up visits. About 80 people are expected to participate, and the trial is supported by the National Cancer Institute.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with higher-risk MGUS or low-risk SMM.
- Higher-Risk MGUS: Bone marrow plasma cells less than 10% and specific protein levels or abnormal light-chain ratios.
- Low-Risk SMM: Bone marrow plasma cells 10% or more without high-risk features.
- No evidence of active multiple myeloma or related conditions like high calcium levels, kidney issues, anemia, or bone lesions.
- At least 18 years old.
- Good overall health with an ECOG performance status of 0, 1, or 2.
- Specific blood test results within normal ranges.
- Willingness to sign informed consent and participate in the study.
- For those interested in extended treatment, must be randomized to metformin and complete initial assessments.
Exclusion Criteria
- Presence of high-risk smoldering myeloma.
- Diagnosed or treated for another cancer during the study period.
- Currently taking diabetes medications.
- Receiving other investigational treatments.
- Pregnant women or those not using contraception.
- Conditions that increase the risk of metformin-related side effects, such as kidney or liver failure.
- Known intolerance to metformin.
- Conditions affecting medication absorption, like certain bowel diseases or recent bariatric surgery.
- Any other condition that may interfere with the study or metformin use.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Brigham and Women's Hospital | 02115 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Dana-Farber at Brighton | 02135 | Brighton | Massachusetts |
| Dana-Farber at Merrimack Valley | 01844 | Methuen | Massachusetts |
| Dana-Farber at Milford | 01757 | Milford | Massachusetts |
| DF/ BWCC in Clinical Affiliation with South Shore Hospital | 02190 | Weymouth | Massachusetts |
| Dana-Farber at NHOH | 35053 | Londonderry | New Hampshire |
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