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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

Phase 1
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

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

Inclusion Criteria:

- Able to provide written informed consent

- Men and women age ≥ 18 years

- Confirmed diagnosis of multiple myeloma (MM) with measurable disease assessed within
1 month prior to treatment initiation

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

- Eastern Cooperative Oncology Group Scale (ECOG) Performance Status of 0 - 2

- Last MM treatment at least 21 days prior to treatment initiation• Bone marrow
transplant (BMT) at least 3 months prior to treatment initiation

- Required baseline hematology and chemistry parameters

- Resolution of acute toxicity due to prior therapy to Grade <2 per National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Men whose sexual partners are women of child bearing potential (WOCBP) or WOCBP who
are unwilling or unable to use an acceptable method to avoid pregnancy for the entire
study period and for at least one month (4 weeks) before and for at least one month
(4 weeks) after the last dose of study medication.

- Clinically significant cardiac disease (New York Heart Association [NYHA] Class III
or IV)

- Abnormal corrected QT interval using Fridericia's formula (QTcF) interval prolonged
(> 450 msec)

- Medications that are generally considered to have a risk of causing "Torsades de

- Malabsorption syndrome or uncontrolled gastrointestinal toxicities

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

- Clinically-significant coagulation or platelet function disorder

- Dementia, chronic medical or psychiatric condition, or laboratory abnormality

- Other severe, acute, or chronic medical or psychiatric condition or laboratory
abnormality, serious uncontrolled medical disorder or active infection

- Intolerance to dasatinib and/or lenalidomide

- Subjects with a history of severe rash, hypersensitivity reaction or anaphylaxis
related to prior thalidomide treatment

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)

Outcome Description:

The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in < 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT.

Outcome Time Frame:

From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

November 2012

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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