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Protease Inhibitor

Triple Drug Therapy for Multiple Myeloma

Phase 1

Waitlist Available

Led By Wilson I Gonsalves

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to swallow metformin and nelfinavir tablets

Patients must have received at least 2 prior regimens and been exposed to a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

Study Summary

This trial is testing the combination of metformin, nelfinavir, and bortezomib to treat patients with multiple myeloma. Researchers want to see if this combination is more effective than other treatments and what the side effects are.

Who is the study for?

This trial is for patients with relapsed or treatment-resistant multiple myeloma. Participants must have tried at least two prior treatments, including a proteasome inhibitor and an immunomodulatory drug. They should be able to take oral medication, provide blood and bone marrow samples, and not be pregnant or breastfeeding. Exclusions include severe diseases, risk of lactic acidosis, recent major surgery, HIV on antiretroviral therapy, other active cancers needing treatment, uncontrolled illnesses or infections.Check my eligibility

What is being tested?

The study tests the combination of metformin hydrochloride (which may disrupt cancer cell energy), nelfinavir mesylate (an enzyme blocker), and bortezomib (another enzyme blocker) in treating multiple myeloma that has returned after treatment or is non-responsive. The goal is to determine the best dose with manageable side effects.See study design

What are the potential side effects?

Potential side effects include those common to cancer therapies such as nausea, fatigue, digestive issues but also specific ones related to this trial's drugs like increased risk of lactic acidosis from metformin and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow pills without difficulty.

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I have had at least 2 treatments including a PI, an IMiD, and an anti-CD38 antibody.

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My multiple myeloma is currently getting worse.

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My multiple myeloma shows up on tests.

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I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose of the combination of metformin, nelfinavir, and bortezomib

Secondary outcome measures

Hematologic response rate

Incidence of adverse events

Other outcome measures

Clinical biomarker analysis

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (metformin, nelfinavir)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib D-mannitol

FDA approved

Nelfinavir

FDA approved

Metformin

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,131 Total Patients Enrolled

76 Trials studying Multiple Myeloma

9,702 Patients Enrolled for Multiple Myeloma

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,480 Total Patients Enrolled

579 Trials studying Multiple Myeloma

189,122 Patients Enrolled for Multiple Myeloma

Wilson I GonsalvesPrincipal InvestigatorMayo Clinic in Rochester

3 Previous Clinical Trials

133 Total Patients Enrolled

3 Trials studying Multiple Myeloma

133 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Is Metformin Hydrochloride deemed an innocuous treatment option?

"Considering the limited data available on Metformin Hydrochloride's safety and efficacy, our team at Power has rated this medication with a score of 1."

Answered by AI

Are there any past experiments on Metformin Hydrochloride's efficacy?

"At the present time, 313 clinical trials are being conducted on Metformin Hydrochloride with 80 of those trials in Phase 3. There is a large number of sites offering this treatment (9847), though most studies take place in Traverse City, Michigan."

Answered by AI

In what health conditions is Metformin Hydrochloride typically utilized?

"Metformin Hydrochloride is chiefly used to manage exercise-induced illnesses, yet it may also be given for type 1 diabetes mellitus, diabetic ketoacidosis and multiple myeloma."

Answered by AI

What is the current enrollment quota for this research endeavor?

"This clinical trial is no longer recruiting participants, having been initially posted on April 17th 2019 and last updated on September 22nd 2022. However, there are 807 ongoing studies for multiple myeloma patients as well as 313 trials focusing specifically on Metformin Hydrochloride that are still seeking volunteers."

Answered by AI

Are there currently any vacancies for participants of this medical experiment?

"Unfortunately, this clinical trial is no longer recruiting participants. It was originally listed on April 17th 2019 and saw its last edit on September 22nd 2022. There are currently 807 active trials for multiple myeloma and 313 studies offering Metformin Hydrochloride available to prospective patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metformin, Nelfinavir, and Bortezomib in Treating Patients With Relapsed and/or Refractory Multiple Myeloma

2019. "Metformin, Nelfinavir, and Bortezomib in Treating Patients With Relapsed and/or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03829020.

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