Metformin Hydrochloride for Multiple Myeloma

Phase-Based Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Rochester, Rochester, MN
Multiple Myeloma+3 More
Metformin Hydrochloride - Drug
Eligibility
18+
All Sexes
Eligible conditions
Multiple Myeloma

Study Summary

This study is evaluating whether a combination of drugs may be more effective than a single drug in treating multiple myeloma.

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Eligible Conditions

  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Refractory Plasma Cell Myeloma
  • Recurrent Plasma Cell Myeloma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Metformin Hydrochloride will improve 1 primary outcome, 2 secondary outcomes, and 1 other outcome in patients with Multiple Myeloma. Measurement will happen over the course of 42 days.

42 days
Maximum tolerated dose of the combination of metformin, nelfinavir, and bortezomib
Up to 2.5 years
Clinical biomarker analysis
Hematologic response rate
Incidence of adverse events

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (metformin, nelfinavir)

This trial requires 36 total participants across 2 different treatment groups

This trial involves 2 different treatments. Metformin Hydrochloride is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Treatment (metformin, nelfinavir)Patients receive metformin hydrochloride PO on days 1-14, nelfinavir mesylate PO BID on days 1-14, and bortezomib SC on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nelfinavir
FDA approved
Metformin
FDA approved
Bortezomib D-mannitol
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2.5 years for reporting.

Closest Location

Mayo Clinic in Rochester - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Monoclonal bone marrow plasmacytosis is present if there are >= 10% plasmacytocytes in the bone marrow. show original
To be eligible for the study, patients must have received at least 2 prior regimens, which should have included treatment with a proteasome inhibitor (PI), an immunomodulatory drugs (IMiD), and an anti-CD38 antibody show original
The Eastern Cooperative Oncology Group (ECOG) performance status (PS) classifies people with cancer according to how active they are show original
This patient's hemoglobin was 8.0 g/dL or higher, so they should not have received a red cell transfusion within the previous four days show original
Actively relapsing multiple myeloma
Serum monoclonal protein >= 0.5 g/dL
If you have high levels of immunoglobulin A (IgA), it may mean that you have an immune system disorder. show original
At least 200 milligrams of monoclonal protein was found in the urine on a 24-hour electrophoresis test. show original
If the serum immunoglobulin free light chain is greater than or equal to 10 mg/dL and the serum immunoglobulin kappa to lambda free light chain ratio is abnormal, then the individual has a plasma cell dyscrasia. show original
The patient must have an absolute neutrophil count (ANC) of at least 1000/mm^3 within the past two weeks. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes multiple myeloma?

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Multiple myeloma develops as a result of a problem in the myeloma cells (i.e. the B cells that produce antibody) that normally destroy viruses. It is a disorder that is dependent on environmental factors affecting the development of the myeloma cells.

Unverified Answer

Can multiple myeloma be cured?

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Patients with MM are likely to relapse. Some patients may experience remissions. The disease does not necessarily progress to lethal bony involvement, and in a few patients, plasma cell dyscrasias may respond to high-intensity chemotherapy. The current data suggest that MM may be a curable disease in a small subset of patients if remission occurs in time to allow for autograft in patients who have responded to conventional treatment.

Unverified Answer

How many people get multiple myeloma a year in the United States?

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By 2013, approximately 18.3 million US adults will be diagnosed with at least one type of blood cancer. This makes up 4.7% of the US adult population.

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What are the signs of multiple myeloma?

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Multiple myeloma can present with a series of symptoms including pain, decreased appetite, or a change in appetite, easy bruising and bleeding, and a high blood protein level. The most common symptom is bone pain and the change in the level of protein in the blood. Tumour mass in myeloma can also cause the bones to become broken or fractured as a result of bone pain and weakness.\n- www.hscbbc.co.

Unverified Answer

What are common treatments for multiple myeloma?

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The common treatment options for multiple myeloma patients are [biological therapy] and [immunotherapy]; [chemotherapy/immunotherapy + prednisone/biological therapy] and [bisphosphonates/immunotherapy + prednisone/biological therapy]. We recommend using the most appropriate treatment in each patient. If the [prognosis], [outcomes], or [outpatient support group membership is good], we recommend using the standard-of-care treatment. [Imnunotherapy + dexamethasone is a good choice if there is a bone lesion, hypercalcemia, or symptomatic cardiac arrhythmia.

Unverified Answer

What is multiple myeloma?

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Data from a recent study, we investigated the use of serum KLH as an immunomarker for diagnosing MM. A positive result in serum KLH testing was indicative of MM and was very specific, with both MM patients and control MZL patients displaying a positive, albeit more weak, reactivity relative to normal serum. Overall, our findings support the view that serum KLH, as a biomarker for MM, may be more specific than immunofixation, a commonly used method for diagnosis of MM. Moreover, serum KLH testing has the potential to outperform both immunofixation and the conventional diagnostic method of MZL.

Unverified Answer

Does metformin hydrochloride improve quality of life for those with multiple myeloma?

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MM patients are able to take part in an AMH clinical trial. After the introduction of AMH in patients with multiple myeloma from 2015, the survival rate increased significantly and QOL was improved. AMH for multiple myeloma treatment is therefore recommended.

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What is the primary cause of multiple myeloma?

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Data from a recent study is the first to elucidate the primary cause of MM in the Korean population. A significant and high proportion of patients with MM were classified as having a nondiagnostic bone marrow lesion. Of those, 12.6% were diagnosed as having an unknown primary malignancy. The most common lesions were non-lymphoid neoplasias, predominantly [myelopoiesis (7.6%) and monoclonal gammopathy of undetermined significance (MUS, 6.6%)] and multiple myeloma (5.8%). Data from a recent study suggest that a careful examination of bone marrow and detection of unknown primary lesions would be important during initial work-up of patients with MM when considering treatment.

Unverified Answer

How does metformin hydrochloride work?

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The combination of this drug and low-dose thalidomide is more effective than other drugs used to treat multiple myeloma at inducing a partial remission and delaying progression in patients with multiple myeloma for up to 4 years after starting therapy. However, metformin hydrochloride does not have much effect on the duration or nature of multiple myeloma patients with a normal level of kidney function.

Unverified Answer

What does metformin hydrochloride usually treat?

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Metformin hydrochloride may be indicated for refractory multiple myeloma, based on preliminary evidence from a single observational study but this should be confirmed by an adequately powered RCT before its use can be recommended in clinical practice. Furthermore, other agents may be more effective than metformin and therefore may be preferred for patients with high-risk multiple myeloma. Metformin and other oral hypoglycaemic agents should be used with care during pregnancy and hence should not be routinely used during pregnancy.

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What are the common side effects of metformin hydrochloride?

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The most common side effects of metformin hydrochloride were headache, nausea, and GI bleeding. The rate of nausea and GI bleeding was <5%. Thus it appears safe or feasible to take metformin hydrochloride for longer duration for patients with multiple myeloma or the treatment of type 2 diabetes.

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Have there been other clinical trials involving metformin hydrochloride?

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The authors cannot provide a summary of a clinical trial of metformin hydrochloride due to FDA rules and the lack of FDA documentation; however, they confirm that there were clinical trials of metformin hydrochloride use among patients with multiple myeloma.

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