IFM2009-02-Pomalidomide and Dexamethasone Phase 2 Myeloma

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the response to pomalidomide and dexamethasone in relapse and refractory MM patients who are progressive and did not achieve at least a partial response to bortezomib and lenalidomide. This study will determine the efficacy and toxicity profile of 2 modalities of pomalidomide in patients with advanced myeloma, previously heavily treated characterized with adverse prognostic and that are in desperate need of novel therapeutics.

• 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

Key inclusion criteria:

• Must be able to understand and voluntarily sign an informed consent form

• Must be able to adhere to the study visit schedule and other protocol requirements

• 18 years>=Age

• Life expectancy>6 months

• Patients must have Symptomatic and Progressive Myeloma following bortezomib and/or lenalidomide treatment, defined as detailed in protocol.

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

• ECOG performance status score of 0,1,or 2

• Adequate bone marrow function,documented within 72 hours prior to treatment without transfusion or growth factor support,defined as*

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

• Able to take antithrombotic medicines such as Low molecular weight heparin or Aspirin 75mg

• Subjects affiliated with an appropriate social security system

• Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy

• Agree not to share study medication with another person and to return all unused study drug to the investigator

• Female subjects of childbearing potential* must:Understand that the study medication is expected to have a teratogenic risk-Agree to use,and be able to comply with, effective contraception* without interruption,4 weeks before starting study drug,throughout the entire duration of study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy,even if she has amenorrhoea.This applies unless the subject commits to absolute and continued abstinence on a monthly basis-Understand that even if she has amenorrhea,she must follow all the advice on effective contraception-She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy-Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/mL on the day of the study visit or in the 3 days prior to the study visit once the subject has been on effective contraception for at least 4 weeks-Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment,except in the case of confirmed tubal sterilization. These pregnancy tests should be performed on the day of the study visit or in the 3 days prior to the study visit.This requirement also applies to women of childbearing potential who practice complete and continued abstinence

• Male subjects must:Agree to use condoms throughout study drug therapy,during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception Agree not to donate semen during study drug therapy and for one week after end of study drug therapy

Exclusion Criteria:

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

• Pregnant or breast feeding females

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

• Known positive for HIV or infectious hepatitis,type A, B or C.

• Patients with non-secretory MM

• Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for >= 3 years.Exceptions include the following*

• Prior local irradiation within two weeks before screening

• Evidence of central nervous system involvement

• Any>grade 2 toxicity unresolved

• Peripheral neuropathy>=Grade 2

• Known Hypersensitivity to Thalidomide,Lenalidomide or Dexamethasone

• Ongoing active infection,especially ongoing pneumonitis

• Ongoing Cardiac dysfunction

• Inability or unwillingness to comply with birth control requirements

• Unable to take antithrombotic medicines at study entry

• Unable to take corticotherapy at study entry

• Refusal to participate in the study

• Persons protected by a legal regime(guardianship,trusteeship)

(*)=described in protocol