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Alkylating agents

Bendamustine + Pomalidomide + Dexamethasone for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Led By Gwynn Long, MD

Research Sponsored by Cristina Gasparetto

Eligibility Criteria Checklist

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

Must have

Cytopathologically or histologically confirmed diagnosis of multiple myeloma

Agree to take enteric coated aspirin 81 mg daily

Must not have

Exposure to chemotherapy or steroids within 14 days of study-related drug therapy

Prior use of pomalidomide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years after last dose of study drug

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

Summary

This trial is a phase I-II open label study testing a combination of pomalidomide, bendamustine, and dexamethasone as a treatment for relapsed or refractory multiple myeloma.

Who is the study for?

This trial is for adults over 18 with relapsed or refractory multiple myeloma, who have seen their cancer progress after treatment, including lenalidomide. They should have a life expectancy of more than 3 months and be able to perform daily activities with minimal assistance (ECOG Performance Status of 0-2). Their liver function must also meet certain criteria.

What is being tested?

The study tests a combination of three drugs: Pomalidomide taken orally for the first 21 days of each cycle, Bendamustine given intravenously on day one, and Dexamethasone administered weekly either orally or IV. After initial cycles, doses may adjust and continue until disease progression.

What are the potential side effects?

Possible side effects include fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems, allergic reactions from IV medication infusion, liver issues indicated by abnormal blood tests results.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis of multiple myeloma is confirmed through testing.

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I agree to take a low-dose aspirin daily.

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My condition worsened despite taking the full dose of lenalidomide for at least two cycles.

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My cancer has worsened or returned after treatment.

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I am over 18 years old.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken chemotherapy or steroids in the last 14 days.

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I have previously taken pomalidomide.

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I have been diagnosed with POEMS syndrome.

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I have been diagnosed with primary systemic amyloidosis.

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I haven't used any experimental drugs or therapies in the last 21 days.

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I have been diagnosed with Waldenström's macroglobulinemia.

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I have not had major surgery in the last 3 weeks.

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I haven't had heart failure, chest pain, irregular heartbeats, or a heart attack in the last six months.

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My high blood pressure is not under control.

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I have not taken antibiotics, antivirals, or antifungals for an infection in the last 14 days.

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I do not have any mental or physical health conditions that would interfere with treatment.

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I do not have severe nerve pain or damage.

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I cannot take certain medications required for the trial due to adverse reactions.

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I have been diagnosed with plasma cell leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years after last dose of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years after last dose of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after last dose of study drug for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Initial Response Rate

Maximum Tolerated Dose of Pomalidomide and Bendamustine

Secondary study objectives

Overall Response Rate

Progression Free Survival

Time to Next Therapy

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: ExpansionExperimental Treatment3 Interventions

* Pomalidomide 3mg: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine 120 mg: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

Group II: Cohort 2: benda 120mg + pom 4mgExperimental Treatment3 Interventions

* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

Group III: Cohort 1: benda 120mg + pom 3mgExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

Bendamustine

FDA approved

Pomalidomide

FDA approved

0 / 20Eligibility criteria met