Investigation of Metformin for the Prevention of Progression of Precursor Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT04850846 |
Recruitment Status :
Recruiting
First Posted : April 20, 2021
Last Update Posted : August 15, 2023
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | March 18, 2021 | ||||||||||||||
First Posted Date ICMJE | April 20, 2021 | ||||||||||||||
Last Update Posted Date | August 15, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | April 27, 2021 | ||||||||||||||
Estimated Primary Completion Date | July 31, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
(M-)protein concentrations/light chains change [ Time Frame: Baseline to 6-months ] Assessed by using the serum-protein electrophoresis and serum-free light chain assays
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Investigation of Metformin for the Prevention of Progression of Precursor Multiple Myeloma | ||||||||||||||
Official Title ICMJE | A Randomized Placebo-Controlled Phase 2 Study of Metformin for the Prevention of Progression of Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma | ||||||||||||||
Brief Summary | 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:
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Detailed Description | This is a Phase 2, double-blind, randomized placebo-controlled trial in patients with higher-risk monoclonal gammopathy of undetermined significance (MGUS) and low-risk smoldering multiple myeloma (SMM) to test the efficacy of metformin in reducing clinical indicators of disease progression in MGUS and SMM patients. Metformin is considered "investigational", which means it has not been approved for the study of cancer prevention by the United States Food and Drug Administration. It has been approved for other uses including for blood sugar control in some people with Type II diabetes. Multiple myeloma is a cancer of the plasma cells, which is an important part of the immune system. Patients with active multiple myeloma generally require treatment. There are currently no approved therapies for MGUS and SMM patients. Metformin is a medication that is commonly used in the treatment of diabetes. Metformin works by decreasing glucose production in the liver, decreasing glucose absorption, and improving insulin sensitivity. This study is interested in studying this medication because several recent studies indicate that the drug may help prevent progression in patients with MGUS or SMM. This study is looking to learn more about whether metformin will benefit patients with MGUS or SMM who may not have diabetes. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. After enrollment participants will be randomized assigned to receive either the Placebo or Metformin pills and to take them for 6 months depending on participant tolerance to the drug. Participants will have the option to learn their treatment assignment after primary (6-month) outcome assessments are complete, and individuals randomized to metformin will have the opportunity to continue to take metformin for an additional 6-months to allow for the observation of potentially longer-term treatment response. Participants who choose to be unblinded and are taking placebo will discontinue study medication. It is expected that about 80 people will take part in this research study. The National Cancer Institute of the National Institutes of Health is supporting this trial. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
80 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | January 31, 2025 | ||||||||||||||
Estimated Primary Completion Date | July 31, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: -Diagnosed with higher-risk MGUS or low-risk SMM defined below: --Higher-Risk MGUS: bone marrow plasma cell concentration <10%# AND either serum M-protein level ≥1.5 g/dL to <3 g/dL or abnormal free light-chain (FLC) ratio (<0.26 or>1.65) or IgA MGUS. Note: individuals with an abnormal FLC ratio that are classified as light-chain only are eligible. Light-chain only patients are defined as complete loss of immunoglobulin heavy-chain, accompanied by abnormal FLC ratio with an increased level of the appropriate involved light-chain (increased kappa FLC in patient with ratio >1.65, and increased lambda FLC in patients with ratio <0.26).
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||
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Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04850846 | ||||||||||||||
Other Study ID Numbers ICMJE | 21-008 K22CA251648 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Omar Nadeem, MD, Dana-Farber Cancer Institute | ||||||||||||||
Original Responsible Party | Irene Ghobrial, MD, Dana-Farber Cancer Institute, Principal Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | August 2023 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |