Dasatinib in Combination With Revlimid (and Dexamethasone)

Condition(s) targeted: Multiple Myeloma

Intervention: Dasatinib + Lenalidomide + Dexamethasone (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

The purpose of this study is to determine the safety and tolerability of dasatinib when given in combination with lenalidomide and dexamethasone for the treatment of relapsed or refractory multiple myeloma.

Official title: A Phase I Single Arm Dose Escalation Study of the Combination of Dasatinib (Sprycel®) With Lenalidomide (Revlimid®) and Dexamethasone in Subjects With Relapsed and/ or Refractory Multiple Myeloma

Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study

Primary outcome:

Determination of Maximum Tolerated Dose through dose escalation

Safety and Tolerability

Secondary outcome:

Tolerability of the combination

Recommended dose of the combination for future Phase II studies

Observation of presence/absence of any antitumor activity

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Able to provide written informed consent

- Men and women age ≥ 18 years

- Confirmed diagnosis of MM with measurable disease

- Evidence of relapsed or refractory disease and at least one prior therapy for MM

- ECOG Performance Status 0 - 2

- Last MM treatment not within 21 days prior to study treatment initiation

- BMT not within 3 months prior to study treatment initiation

- Required baseline hematology and chemistry parameters

Exclusion Criteria:

- Clinically significant cardiac disease (NYHA Class III or IV)

- Abnormal QTcF interval prolonged (> 450 msec)

- Malabsorption syndrome or uncontrolled gastrointestinal toxicities

- Clinically significant pleural effusion in the previous 12 months or current ascitis

- Clinically-significant coagulation or platelet function disorder

- Intolerance to dasatinib and/or lenalidomide

For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

Local Institution, Lille Cedex 59037, France; Recruiting
Site 006

Local Institution, Vandoeuvre Les Nancy 54511, France; Not yet recruiting
Site 009

Local Institution, Toulouse Cedex 03 31059, France; Not yet recruiting
Site 010

Local Institution, Rotterdam 3015 CE, Netherlands; Recruiting
Site 005

Local Institution, Scottsdale, Arizona 85259, United States; Not yet recruiting
Site 001

The Cancer Center At Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Suspended

Local Institution, Waratah, New South Wales 2298, Australia; Not yet recruiting
Site 011

Local Institution, Prahran, Victoria 3181, Australia; Not yet recruiting
Site 008

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: May 2008
Ending date: January 2011
Last updated: October 20, 2008