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Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma

NCT01754402 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-02-20

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Bendamustine

Bendamustine will be administered intravenously over 1 hour (if using Treanda) or over 10 minutes (if using Bendeka) on day 1, every 28 days for 12 cycles.

DRUG

Pomalidomide

Pomalidomide will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.

DRUG

Dexamethasone

Dexamethasone will be administered weekly orally or intravenously on days 1, 8, 15, and 22 every 28 days until disease progression or death. After 6 cycles of treatment, the dose may be reduced to 20mg at investigator's discretion. For subjects ≥ 75 years of age, the starting dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of each 28-day treatment cycle.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Cristina Gasparetto

    lead OTHER

Principal Investigators

  • Gwynn Long, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-07
Primary Completion
2016-12-06
Completion
2025-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01754402 on ClinicalTrials.gov