Progressive/Refractory multiple myeloma. MedDRA version: 16.1 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 100000004851
Conditions
Interventions
Product Name: Pomalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: POMALIDOMIDE
CAS Number: 19171-19-8
Current Sponsor code: CC-4047
Other descriptive name: POMALIDOMIDE
Trade Name: D
Sponsors
INSTITUT CURIE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients must have been treated in first line within the IFM/DFCI 2009 trial 2.Must be able to understand and voluntarily sign an informed consent form 3.Must be able to adhere to the study visit schedule and other protocol requirements 4.Age = 18 years 5.Life expectancy > 6 months 6.Patients must have symptomatic and progressive Myeloma as defined by the IMWG criteria 7.Patients must have a clearly detectable and quantifiable monoclonal M-component value 8.Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 9.Adequate bone marrow function, documented within 96 hours prior to treatment without transfusion or growth factor support 10.Adequate organ function, documented within 96 hours prior to treatment. 11.Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment. 12.Able to take antithrombotic medicines such as low molecular weight heparin or aspirin. 13.Subjects affiliated with an appropriate social security system 14.Agree to abstain from donating blood while taking study drug therapy and for at least 28 days following discontinuation of study drug therapy 15.Agree not to share study medication with another person and to return all unused study drug to the investigator 16.Female subjects of childbearing potential must: - Understand the potential teratogenic risk to the unborn child - Understand the need and agree to use, and be able to comply with, two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. Females of childbearing potential must be referred to a qualified provider of contraceptive methods if needed. 17.Male subjects must: - Practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy. - Agree not to donate semen or sperm during study drug therapy and for at least 28 days following discontinuation of study drug. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1.Any other uncontrolled medical condition or comorbidity that might interfere with subject’s participation 2.Primary amyloidosis or myeloma complicated by amyloidosis 3.Pregnant or breast feeding females 4.Use of any other experimental drug or therapy within 2 weeks before study treatment initiation(except local radiotherapy and/or corticosteroid until dose of dexamethasone 160mg) 5.Known positive for HIV or Active infectious hepatitis, type B or C 6.Patients with non-secretory MM 7.Prior history of malignancies within 10 years 8.Evidence of Central Nervous System (CNS) involvement 9.Any > grade 2 toxicity unresolved 10.Peripheral neuropathy > grade 2 11.Known hypersensitivity to thalidomide, lenalidomide, cyclophosphamide or dexamethasone 12.Ongoing active infection, especially ongoing pneumonytis 13.Participant with clinical signs of heart or coronary failure, or evidence of Left Ventricular Ejection Fraction (LVEF) inferior to 40%. Participant with myocardial infarction within 6 months prior to enrolment or have New York Heart Association (NYHA) Class III or IV heart failure, and controlled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities 14.Inability or unwillingness to comply with birth control requirements 15.Unable to take antithrombotic medicines at study entry 16.Unable to take corticotherapy at study entry 17.Individually deprived of liberty or placed under the authority of a tutor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine Response rate to the triple combination of pomalidomide and cyclophosphamide and dexamethasone in MM patients who are progressive after having received a first line of therapy according to the IFM/DFCI 2009 trial. ;Secondary Objective: -To determine safety of pomalidomide associated to cyclophosphamide and dexamethasone. -To determine time to response and response duration of pomalidomide associated to cyclophosphamide and dexamethasone. -To determine time to disease progression to pomalidomide associated to cyclophosphamide and dexamethasone. -Overall Survival (OS) of pomalidomide associated to cyclophosphamide and dexamethasone. -To determine response with regards to previous IFM/DFCI 2009 trial treatment arm (Arm A vs arm B) as well as cytogenetic of the bone marrow tumor plasma cells. ;Primary end point(s): The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the studied population using International Myeloma Working Group (IMWG) response criteria [Rajkumar, 2011].;Timepoint(s) of evaluation of this end point: The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety (type, frequency, severity, and relationship of Adverse Events (AE) to study treatment). Incidence of AE, Serious Adverse Event (SAE) and laboratory abnormalities using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTC AE) V4.03. - Time to response (from the date of inclusion to the date of the first observation of response) and response duration (time between first documentation of response and disease progression). - Time to disease progression (from the date of the first dose to the date of the first observation of disease progression). - Overall Survival (OS) (from the date of inclusion to the date of the last news). - To determine response with regards to previous IFM/DFCI 2009 trial treatment arm (Arm A vs arm B) as well as cytogenetic of the bone marrow tumor plasma cells. Analysis of cytogenetic study of bone marrow plasma cells is a key test in myeloma. The following cytogenetic FISH studies (Deletion 13q, Deletion 17p, translocation 4;14) will be performed (by Pr H. Avet Loiseau, Toulouse, France) at study entry. ;Timepoint(s) of evaluation of this end point: - At end of treatment with pomalidomide - Until disease progression - Until disease progression - Until death lost of follow-up - After 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) | — |
Countries
France
Contacts
Public ContactChrystelle GASTRIN
Institut Curie
Outcome results
None listed