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Biguanide
Metformin XR for Preventing Multiple Myeloma
Phase 2
Recruiting
Led By Irene M Ghobrial, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
For participants who wish to enroll in the open label extended treatment (crossover arm), participants can be unblinded and learn of their drug group AFTER completing primary endpoint collection. Patient must be randomized to metformin in order to continue taking metformin for 6 additional months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline- 12 months
Awards & highlights
Study Summary
This trial will study whether metformin can help prevent patients with MGUS and SMM from developing multiple myeloma.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Metformin may cause digestive issues like diarrhea and nausea, a metallic taste in the mouth, low blood sugar levels, vitamin B12 deficiency over long-term use, and very rarely lactic acidosis which is an emergency condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I was randomized to take metformin and can continue it for 6 more months after the main study period.
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My kidneys are functioning well enough to clear waste.
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I am able to care for myself and perform daily activities.
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I have been diagnosed with a higher-risk form of MGUS or low-risk SMM.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline- 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline- 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
(M-)protein concentrations/light chains change
Secondary outcome measures
(M-)protein concentrations/light chains change by mass spectrometry
Changes in PROMIS Global Health Summary Score v1.2
Changes in plasma metabolites measured by liquid chromatography-mass spectrometry
+6 moreSide effects data
From 2016 Phase 4 trial • 532 Patients • NCT0225296514%
Diarrhoea
6%
Abdominal Distension
6%
Nausea
3%
Dizziness
2%
Abdominal Discomfort
2%
Gastrooesophageal Reflux Disease
2%
Vomiting
2%
Hepatic Function Abnormal
2%
Decreased Appetite
2%
Abdominal Pain Upper
2%
Abdominal Pain
2%
Constipation
2%
Upper Respiratory Tract Infection
1%
Hyperhidrosis
1%
Fatigue
1%
Hepatic Steatosis
1%
Dyslipidaemia
1%
Blood uric Acid Increased
1%
Urinary tract Infection
1%
Palpitations
1%
Protein Urine Present
1%
Hyperuricaemia
1%
Hypoglycaemia
1%
Dyspepsia
1%
Frequent Bowel Movements
1%
Hyperlipidaemia
1%
Asthenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metformin IR
Metformin XR
Metformin IR to XR
Trial Design
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 )
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin XR
2013
Completed Phase 4
~9220
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,868 Total Patients Enrolled
1 Trials studying Monoclonal Gammopathy
42 Patients Enrolled for Monoclonal Gammopathy
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,587 Total Patients Enrolled
Catherine R Marinac, PhDStudy DirectorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your AST and ALT levels must be less than 1.5 times the normal limit at the institution where you are being treated.I am 18 years old or older.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.I was randomized to take metformin and can continue it for 6 more months after the main study period.My kidneys are functioning well enough to clear waste.Your blood sugar levels are not too high, with random glucose less than 160 mg/dL or fasting glucose less than 126 mg/dL.I am able to care for myself and perform daily activities.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.My condition is high-risk smoldering myeloma according to the '20-2-20' criteria.I have a condition that affects how my body absorbs medication.You have been diagnosed or treated for another type of cancer during the study period.You do not show signs of specific symptoms related to multiple myeloma or Waldenstrom's macroglobulinemia as described in the provided information.You have experienced bad reactions to metformin in the past.I have been diagnosed with a higher-risk form of MGUS or low-risk SMM.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is participant involvement in this trial?
"Affirmative. Clinicaltrials.gov attests that this clinical trial, which was initially made available on April 27th 2021, is currently seeking participants. The project seeks to recruit 80 patients from 7 distinct medical sites."
Answered by AI
Is Metformin XR a safe and viable treatment option for patients?
"Our team at Power rated Metformin XR's safety a 2, as this is only in its second clinical trial phase and there has yet to be any evidence of efficacy."
Answered by AI
What medical conditions might Metformin XR be a viable solution for?
"Metformin XR is most often employed to treat exercise-related issues, but can also assist with type 1 diabetes mellitus, diabetic ketoacidosis and polycystic ovary syndrome."
Answered by AI
Has Metformin XR been previously tested in other scientific experiments?
"Currently, there are 170 Metformin XR studies in progress with 43 trials at the Phase 3 stage. Most of these clinical tests take place in Pittsburgh; however, 1903 other centres across the country have also launched investigations into this medication."
Answered by AI
Are there any opportunities to enroll in this experiment right now?
"Per the data available on clinicaltrials.gov, this trial is actively searching for eligible participants. The study was initially announced on April 27th 2021 and has been amended most recently on October 3rd 2022."
Answered by AI
How widespread is the implementation of this clinical trial?
"Seven medical centres are currently enrolling patients in this research endeavour, with the most prominent being Brigham and Women's Hospital located in Boston. Other clinical trial sites include Dana-Farber at Merrimack Valley in Methuen and Dana-Farber at NHOH in Londonderry, complemented by an additional seven locations."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
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