Pomalidomide and Dexamethasone Effects in Multiple Myeloma Patients With Del 17p or t (4;14)

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and toxicity profile of Pomalidomide and Dexamethasone in relapsed or refractory Multiple Myeloma patients with deletion 17p or translocation (4;14)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Collaborator: Celgene Corporation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Pomalidomide; Thalidomide

Criteria

inclusion criteria:

• Able to understand and voluntarily sign an informed consent form

• Age >18 years

• Life expectancy > 6 months.

• Patients must have a Symptomatic and Progressive MM

• Patients must have a clearly detectable and quantifiable monoclonal M-component value

• Eastern Cooperative Oncology Group performance status score of 0, 1, or 2

• Adequate bone marrow function, with no transfusion within 5 days prior to treatment.

• Adequate organ function

• Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment.

• Able to take antithrombotic medicines

• Subjects affiliated with an appropriate social security system.

• Agree to abstain from donating blood while taking study drug therapy and for at least 28 days following discontinuation of study drug .

• Female subjects of childbearing potential (FCBP) (*) must:

Understand the potential teratogenic risk of the treatment and take the relative precaution mentioned in the protocol, in the Pomalidomide information sheet Agree to abstain from breastfeeding during study participation and for at least 28 days after study drug discontinuation

• For female NOT of childbearing potential, pomalidomide is contraindicated unless the exceptions mentioned in the protocol

• Understand the hazards and necessary precautions associated with the use of pomalidomide

• Male subjects must:

• Understand the potential teratogenic risk and take the relative precaution mentioned in the protocol, in the Pomalidomide information sheet

Exclusion criteria :

• Patient that will require allogeneic or autologous transplantation following pomalidomide dexamethasone treatment while in the same course.

• Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation

• Use of any other experimental drug or therapy within 15 days of screening.

• Patients with renal failure that require dialysis and patients with creatinine clearance < 50 mL/min

• Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for ≥3 years. Excepted those mentioned in the protocol.

• Prior local irradiation within two weeks before screening

• Ongoing active infection, especially ongoing pneumonitis

• Ongoing Cardiac dysfunction

• Inability or unwillingness to comply with birth control requirements