MedTrace Logo

A Phase 1 Dose Escalating Trial of Bortezomib in Combination With Lenalidomide in Patients With Myelodysplasia

NCT00580242 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-03-08

No results posted yet for this study

Summary

This study proposes using bortezomib in cohorts of 3-6 patients at the doses of 0.7, 1, and 1.3 mg/m2 on days 1, 4, 8, and 11 to determine the MTD in combination with lenalidomide 10 mg a day, for 21 days of a 28 day treatment cycle for patients with myelodysplastic syndrome.

Conditions

  • Myelodysplasia

Interventions

DRUG

Bortezomib

First cohort: Bortezomib 0.7mg/m2 IV on Days on Days 1, 4, 8, and 11. Patients may receive up to 9 cycles with each cycle lasting a total of 28 days

DRUG

Bortezomib

Second cohort: Bortezomib 1mg/m2 IV on Days 1, 4, 8, and 11 Patients may receive up to 9 cycles with each cycle lasting a total of 28 days

DRUG

Bortezomib

Third Cohort: Bortezomib 1.3mg/m2 IV on Days 1, 4, 8, and 11 of each cycle Patients may receive up to 9 cycles with each cycle lasting a total of 28 days

DRUG

Lenalidomide

Lenalidomide 10 mg PO QD on Days 1 -21 followed by a 7 day rest period

Sponsors & Collaborators

Principal Investigators

  • Karen Ballen, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00580242 on ClinicalTrials.gov