Multiple Myeloma
Conditions
Interventions
Subjects will be treated with a combination of dasatinib, lenalidfomoide and
dexamethasone in 28 day cycles:
In one 28 day cycle, lenalidomide will be administered PO daily from Day 1
through day 21
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to determine the safety and the MTD of dasatinibin combination with lenalidomide and low dose dexamethasone in subjects with relaspsed or refractory multiple myeloma. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Tolerability of the combination - Recommended dose of teh combination for future Phase II studies - Observation of presence/absence of any antitumor activity (by International Uniform Response Critieria for Multiple Myeloma and EBMT Criteria) reported as response rate, duration of response, time to progression and progression free survival. | — |
Countries
Netherlands
Outcome results
None listed