Bendamustine + Pomalidomide + Dexamethasone for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen by Gwynn Long, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Cristina Gasparetto

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study is designed as a phase I-II, open label, dose finding study. Study treatment will be as follows, in 28 day cycles: * Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenously (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22. After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per investigator discretion. After completing 12 cycles of treatment, patients will proceed to the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28 days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.

Eligibility Criteria

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.

Inclusion Criteria

Consent

My diagnosis of multiple myeloma is confirmed through testing.

I can have blood transfusions if needed for my health.

Exclusion Criteria

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

I have previously taken pomalidomide.

I have not had radiation therapy in the last 14 days.

Participant Groups

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.

Group I: Expansion Experimental Treatment 3 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 4mg Experimental Treatment 3 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 3mg Experimental Treatment 3 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

Bendamustine is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Treanda for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

🇪🇺 Approved in European Union as Ribomustin for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma
• Multiple myeloma

🇨🇦 Approved in Canada as Levact for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

🇯🇵 Approved in Japan as Bendamustine hydrochloride for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Duke University Medical Center Durham, NC

Who Is Running the Clinical Trial?

Cristina Gasparetto Lead Sponsor

Celgene Industry Sponsor

References