Patients with Multiple Myeloma in relapsed or refractory MedDRA version: 17.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Filanesib
Product Code: 885060-09-3
Pharmaceutical Form: Solution for injection
INN or Proposed INN: filanesib
CAS Number: 885060-09-3
Current Sponsor code: ARRY-520
Concentration unit:
Sponsors
Fundación Pethema
Eligibility
Sex/Gender
All
Inclusion 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. 5.Patients previously diagnosed with MM according to the IMWG Criteria (Blood 2011)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 require therapy due to a relapse/progression of the disease. 6.Regarding the disease history, patient must: a.Have received 2 prior lines of therapy including bortezomib and lenalidomide. b.Be refractory or intolerant to lenalidomide. c.Be refractory to the last line of therapy. (Refractoriness to any therapy is defined as either failure to achieve minimal response with it, or development of progressive disease (PD) while on therapy or within 60 days after finishing it. At least two cycles of treatment must have been received, unless PD is documented earlier.) 7.Only for the Phase II, patients must have measurable disease, defined as any of the following: a.Serum monoclonal protein value ? 500 mg/dl. b.Urine light chain excretion ? 200 mg/24 hours. c.Abnormal serum free light chains (FLCs) plus involved FLC level ? 10 mg/dl. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1.Prior therapy with Filanesib or pomalidomide. 2.Non-adequate hematological or biochemical parameters as specified below: a.Hemoglobin 50%) is present, ? 50 x109/L platelet count is required. c.Neutrophils (ANC) 2.5 x the upper limit range. e.Alanine transaminase (ALT): > 2.5 x the upper limit range. f.Total bilirubin: > 2 x the upper limit range. g.Creatinine clearance: < 45 mL/min (measured or calculated with the Cockcroft and Gault formula). 3.Absence of recovery from any significant non-hematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade < 2 symptomatic peripheral neuropathy is allowed. 4.Concomitant anti-myeloma therapy, including corticosteroids at a dose greater than 10 mg/d prednisone or equivalent, within 14 days prior to Day 1 of Cycle 1. 5.Pregnant or lactating women; men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception). 6.Previous history of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site). 7.Other relevant diseases or adverse clinical conditions: a.Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study. b.Uncontrolled arterial hypertension or cardiac arrhythmias (i.e. requiring a change in medication within the last 3 months or a hospital admission within the past 6 months). c.History of significant neurological or psychiatric disorders. d.Active infection. e.Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis). f.Uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months). 8.Patient is known to be human immunodeficiency virus (HIV) positive, Hepatitis B surface antigen-positive or active hepatitis C infection. 9.Limitation of the patient's ability to comply with the treatment or follow-up protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?To evaluate safety and determine the MTD of Filanesib in combination with pomalidomide and dexamethasone in R/R Multiple Myeloma (MM) patients.;Secondary Objective: N/A;Primary end point(s): ?The grade and frequency of clinical and laboratory toxicities (AE/SAEs), DLTs, and treatment discontinuations after Filanesib in combination with pomalidomide + dexamethasone ?MTD of the combination of Filanesib + pomalidomide + dexamethasone;Timepoint(s) of evaluation of this end point: ?During the treatment ?During the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Spain
Contacts
Public ContactFundación Pethema
Fundación Pethema
Outcome results
None listed