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Alkylating agents

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years after last dose of study drug

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Initial Response Rate

Maximum Tolerated Dose of Pomalidomide and Bendamustine

Secondary outcome measures

Overall Response Rate

Progression Free Survival

Time to Next Therapy

+1 more

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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cristina GasparettoLead Sponsor

2 Previous Clinical Trials

54 Total Patients Enrolled

1 Trials studying Multiple Myeloma

18 Patients Enrolled for Multiple Myeloma

CelgeneIndustry Sponsor

636 Previous Clinical Trials

128,915 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,807 Patients Enrolled for Multiple Myeloma

Gwynn Long, MDPrincipal InvestigatorDuke University

1 Previous Clinical Trials

17 Total Patients Enrolled

1 Trials studying Multiple Myeloma

17 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.

What are the main conditions that doctors treat with Bendamustine?

"bendamustine, while most often used to treat ophthalmia, sympathetic, can also be helpful for branch retinal vein occlusion, macular edema and communicable diseases."

Answered by AI

Could you provide an update on how many individuals are included in this clinical trial?

"This particular study is not recruiting patients at the moment, as evidenced by an original posting date of January 7th, 2013 and most recent update on July 23rd, 2018. However, there are 827 clinical trials for multiple myeloma and 673 trials for Bendamustine that are currently looking for participants."

Answered by AI

Are people still being accepted into this clinical trial?

"This particular study is no longer recruiting patients. The trial was first posted on January 7th, 2013 and received its last edit on July 23rd, 2018. However, there are 827 other trials for multiple myeloma and 673 trials for Bendamustine that are still looking for participants."

Answered by AI

What are the goals that researchers are hoping to achieve with this clinical trial?

"This clinical trial's primary outcome, which will be assessed after approximately 2 months, is the Maximum Tolerated Dose of Pomalidomide and Bendamustine. Secondary outcomes include Progression Free Survival (time from starting study therapy to disease progression or death), Time to Progression (time from response to disease progression), and Time to Next Therapy (time from starting study therapy to starting next therapy)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma

Cristina Gasparetto 2013. "Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01754402.

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