Evaluation of pomalidomide with dexamethasone (low dose) in patients with Multiple Myeloma (MM)whose disease did not respond to the previous treatment or, has come back after the previous treatment.
- Conditions
- Refractory multiple myeloma (MM) or relapsed and refractory MMMedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-001888-78-IT
- Lead Sponsor
- CELGENE CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 682
1.Must be=18yrs at the time of signing the ICD 2.pt must understand and sign an ICD prior to any study related assessments/procedures 3.Must be able to adhere to the study visit schedule/protocol requirements 4.Pts must have documented diagnosis of MM and measurable disease(serum M-protein=0.5g/dL or urine M-protein=200mg/24 hours) 5.Pts must have undergone prior treatment with =2treatment lines of anti-myeloma therapy.Induction therapy followed by ASCT and consolidation/maintenance will be considered as 1line.A new treatment line is always started after PD 6.Pts must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60days of completing their last myeloma therapy Primary refractory:Pts who never achieved any response better than PD to any previous line of anti-myeloma therapy Relapsed and refractory:Pts who relapsed after having achieved at least stable disease for at least 2cycles of treatment to at least one prior regimen and then developed PD on or within 60days of completing their last myeloma therapy 7.pts must have received at least 2consecutive cycles of prior treatment including lenalidomide and bortezomib,either alone or in combination regimens Pts must have failed both lenalidomide and bortezomib and medical records must be available to provide documentation of the refractoriness that make the subject eligible for the study -pts must have failed treatment with the last lenalidomide-containing regimen in one of the following ways: +Documented PD during or within 60days of completing last treatment with lenalidomide,regardless of the response achieved,or +In case of prior response(=partial response-PR)to lenalidomide and PD >60days,pts must have relapsed within 6months after the last dose of treatment with lenalidomide-containing regimens -All pts must have failed treatment with the last bortezomib-containing regimen in one of the following ways: +Documented PD during or within 60days of completing treatment with bortezomib,regardless of the response achieved,or +In case of prior response(=PR to bortezomib and PD>60days,pts must have relapsed within 6months after the last dose of treatment with bortezomib-containing regimens, Or for non-progressive pts: +pts who have less than minor response(MR and have developed intolerance/toxicity after a minimum of 2cycles of a bortezomib-containing regimen.Toxicity such as>grade2 peripheral neuropathy or=grade2 painful neuropathy.Peripheral neuropathy must resolve to grade1prior to study entry 8.pts must have received adequate prior alkylator therapy in one of the following ways: a.As part of a stem cell transplant;or b.A minimum of 4consecutive cycles of an alkylator based therapy;or c.Progression on treatment with an alkylator;provided that the pt received at least 2 cycles of an alkylator-containing therapy 9.ECOG performance status score of 0,1,or2. 10.Females of childbearing potential(FCBP1)must utilize 2reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28days before starting study drug,while participating in the study(including dose interruptions),and for at least 28days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe. 11.Females must abstain from breastfeeding during study participation and 28days after study drug discontinuation. 12.Males must use a latex
1.Any of the following lab abnormalities: -Absolute neutrophil count<1,000/µL -Platelet count<75,000/µL for subjects in whom <50%of bone marrow nucleated cells are plasma cells;or a platelet count<30,000/µL for subjects in whom =50%of bone marrow nucleated cells are plasma cells.Platelet transfusion is not allowed within the previous 3days before screening. -Creatinine Clearance(CrCl)<45mL/min according to Cockcroft-Gault formula. If CrCl calculated from the 24H urine sample is =45mL/min,subject will qualify for the study -Corrected serum calcium >14mg/dL(>3.5mmol/L) -Hemoglobin <8g/dL(<4.9mmol/L;prior red blood cells transfusion or recombinant human erythropoietin use is permitted) -Serum SGOT/AST or SGPT/ALT>3.0 x upper limit of normal(ULN) -Serum total bilirubin>2.0mg/dL(34.2µmol/L);or>3.0xULN for subjects with hereditary benign hyperbilirubinemia 2.Prior history of malignancies,other than MM unless the subject has been free of disease for=5years.Exceptions include the following: -Basal or squamous cell carcinoma of the skin -Carcinoma in situ of the cervix or breast -Incidental histological finding of prostate cancer(TNM stage of T1a or T1b) 3.Previous therapy with POM 4.Hypersensitivity to thalidomide,lenalidomide,or DEX(this includes =Grade3 rash during prior thalidomide or lenalidomide therapy) 5.Peripheral neuropathy =Grade2 6.Subjects who received allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12months prior to study treatment and who have not discontinued immunosuppressive treatment for at least 4weeks prior to initiation of study treatment and are currently dependent on such treatment 7.Subjects who are planning for or who are eligible for stem cell transplant 8.Subjects with any one of the following: -Congestive heart failure(NY Heart Association Class III or IV) -Myocardial infarction within 12months prior to starting study treatment -Unstable or poorly controlled angina pectoris,including Prinzmetal variant angina pectoris 9.Subjects who received any of the following within the last 14days of initiation of study treatment: -Major surgery(kyphoplasty is not considered major surgery) -Use of any anti-myeloma drug therapy 10.Use of any investigational agents within 28days or 5half-lives(whichever is longer)of treatment,unless approved by the Sponsor 11.Incidence of gastrointestinal disease that may significantly alter the absorption of POM 12.Subjects unable or unwilling to undergo antithrombotic prophylactic treatment 13.Any serious medical condition,lab abnormality,or psychiatric illness that would prevent the subjects from signing the ICD 14.Pregnant or breastfeeding females 15.Known human immunodeficiency virus(HIV)positivity,active infectious hepatitis A,B or C or chronic hepatitis B or C.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the safety of the combination of pomalidomide (POM) and low dose dexamethasone (LD-DEX) in a large cohort of subjects with refractory MM or relapsed and refractory MM;Secondary Objective: -Analyze the population pharmacokinetics of POM and assess POM exposure response relationships in subjects with refractory MM or relapsed and refractory MM administered POM and LD-DEX. -Evaluate efficacy of the combination of POM and LD-DEX in subjects with refractory MM or relapsed and refractory MM;Primary end point(s): Adverse events (AEs) assessment (type, frequency, seriousness, severity, relationship to POM and/or DEX and outcomes), including second primary malignancies (SPM);Timepoint(s) of evaluation of this end point: -AEs: After signing ICD and until 28 days after discontinuation from treatment. -SPM: Every 3 months after signing ICD and up to 5 years after last subject enrollment or longer if clinically indicated.
- Secondary Outcome Measures
Name Time Method