EUCTR2014-002740-41-ES
Active, not recruiting
Phase 1
Phase I/II, Multicenter, Open Label, Clinical Trial of Filanesib (ARRY-520) in combination with Pomalidomide and Dexamethasone for relapsed/refractory MM patients - POMDEFI
Fundación Pethema0 sites24 target enrollmentNovember 25, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with Multiple Myeloma in relapsed or refractory
- Sponsor
- Fundación Pethema
- Enrollment
- 24
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age ?18 years.
- •2\.Performance status (ECOG) ? 2\.
- •3\.Patient is, in the Investigator's opinion, willing and able to comply
- •with the protocol requirements.
- •4\.Patient has given voluntary written Informed Consent before
- •performance of any study\-related procedure not part of normal medical
- •care, with the understanding that consent may be withdrawn by the
- •patient at any time without prejudice to their future medical care.
- •5\.Patients previously diagnosed with MM according to the IMWG Criteria
- •(Blood 2011\) that after previous treatment with one or more regimens
Exclusion Criteria
- •1\.Prior therapy with Filanesib or pomalidomide.
- •2\.Non\-adequate hematological or biochemical parameters as specified
- •a.Hemoglobin \< 8\.0 g/dl.
- •b.Platelets count \< 75 x109/L without previous platelet
- •transfusions in the last 7 days. If high bone marrow infiltration (\>50%)
- •is present, ? 50 x109/L platelet count is required.
- •c.Neutrophils (ANC) \<1\.5 × 109/L without growth factor support
- •(defined as no growth factor administration for at least 14 days prior to
- •observation). If the bone marrow contains ? 50% plasma cells, a
- •neutrophil count ?1\.0 × 109/L is allowed.
Outcomes
Primary Outcomes
Not specified
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