A Phase I Single Arm Dose Escalation Study of the Combination of Dasatinib (Sprycel) with Lenalidomide (Revlimid) and Dexamethasone (Decadron) in Subjects with Relapsed and/or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma10027656
- Registration Number
- NL-OMON31724
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
- Subjects able to provide written informed consent
- Subjects must have confirmed diagnosis of Multiple Myeloma with measure disease as described in section 4.2.1 point 2 of the protocol.
- Subjects must have evidence of relapsed or refractory disease and have received at least 1 prior therapy for multiple myeloma
- Subjects must have received last treatment (ie chemotherapy, biological, immunotherapy or investigational agent [therapeutic or diagnostic]) at least 21 days prior to treatment initiation.
- ECOG performance status score 0-2
- If subjects had a bone marrow transplant , this must be at least 3 months prior to treatment initiation
- All acute toxicity of any prior therapy (radiotherapy, chemotherapy, or surgical procedures) must have resolved to Grade <2, NCI CTCAE, version 3.0
- Adequate baseline laboratory results, refer to section 4.2.1 point 2 h of the protocol
- Aged 18 years +
-Women of child bearing potential (WOCBP) must be using an adequate method of contraception 4 weeks before the study, throughout the study and for at least 4 weeks after the last dose of investigational product.
- WOCBP must have a negative serum or urine pregnancy test within 72 hours of the start of the study drug.
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy 4 weeks before the study, throughout the study and for at least 4 weeks after discontinuing from the study.
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test at enrolment or prior to study treatment
- Men whose sexual partners are WOCBP who are unwilling or unable to use an accepted method of contraception throughout the study and for at least 4 weeks after discontinuing from the study.
- Clinically significant cardiac disease (section 4.2.2 points a and b for examples)
- Malabsorption syndrome or uncontrolled gastrointestinal toxicities (section 4.2.2. point c)
- Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation.
- Clinically significant pleural effusion in the previous 12 months or current ascitis
- Clinically significant coagulation or platelet function disorder (eg, known von Willebrand*s disease).
- Prior of concurrent malignancy (see exceptions in section 4.2.2 point g)
- Intolerance to dasatinib and/or lenalidomide
- medications that are generally considered to have a risk of causing *Torsades de Pointes*, refer to section 5.5.1.1 of the protocol.
- Prisoners or subjects who are compulsory detained for treatment of either a psychiatric or physical illness must not be enrolled
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to determine the safety and the MTD of dasatinibin<br /><br>combination with lenalidomide and low dose dexamethasone in subjects with<br /><br>relaspsed or refractory multiple myeloma.</p><br>
- Secondary Outcome Measures
Name Time Method <p> - Tolerability of the combination<br /><br>- Recommended dose of teh combination for future Phase II studies<br /><br>- Observation of presence/absence of any antitumor activity (by International<br /><br>Uniform Response Critieria for Multiple Myeloma and EBMT Criteria) reported as<br /><br>response rate, duration of response, time to progression and progression free<br /><br>survival.</p><br>