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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 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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,245 Previous Clinical Trials
3,783,432 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,702 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,965,045 Total Patients Enrolled
588 Trials studying Multiple Myeloma
189,452 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
~1 spots leftby Jun 2025
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