Bendamustine + Pomalidomide + Dexamethasone for Multiple Myeloma

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Cristina Gasparetto

Must be taking: Enteric coated aspirin

Must not be taking: Experimental drugs, Chemotherapy

Disqualifiers: Heart failure, Hypertension, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

56 Participants Needed

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.

Research Team

Gwynn Long, MD

Principal Investigator

Duke University

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Patients are enrolled in cohorts to determine the maximum tolerated dose (MTD) using a 3+3 design

2 months

Multiple visits for dose escalation and monitoring

Treatment

Participants receive Bendamustine, Pomalidomide, and Dexamethasone in 28-day cycles for up to 12 cycles

12 months

Monthly visits for treatment administration and monitoring

Maintenance

Participants continue with Pomalidomide and Dexamethasone until disease progression

Until progression

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Bendamustine
• Dexamethasone
• Pomalidomide

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Cristina Gasparetto

Lead Sponsor

Trials

3

Recruited

110+

Celgene

Industry Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania