A Multicenter Open label Phase II study of Pomalidomide and Dexamethasone in Progressive Relapsed or Refractory Multiple Myeloma patients with deletion 17p or translocation (4;14) Adverse Karyotypic Abnormalities. IFM 2010-02

• Conditions: This study will determine the efficacy and toxicity profile of pomalidomide and dexamethasone in patients with adverse prognostic factors as determined using adverse karyotypic abnormalities and that are in desperate need of novel therapeutics.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002081-20-FR
• Lead Sponsor: CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-30
• Last Update Posted: 2 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Must be able to understand and voluntarily sign an informed consent form
2.Must be able to adhere to the study visit schedule and other protocol requirements
3. Age >18 years
4. Life expectancy > 6 months.
5. Patients must have a relapsed or refractory myeloma, with progressive disease as defined by the IMWG and must have received prior therapy with lenalidomide (at least 2 cycles, being not intolerant to lenalidomide, whatever resistant or responsive to lenalidomide)
6. Patients must have a Symptomatic and Progressive MM
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, with no transfusion within 5 days prior to treatment
10. Adequate organ function
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 75mg
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 .
15. Agree never to give the study medication to another person and to return any unused capsules to the investigator at the end of treatment. Only enough pomalidomide for one cycle of therapy may be dispensed with each cycle of therapy
16.Female subjects of childbearing potential (FCBP) (*) must take special precautions as described in the information letter and in the consent form
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patient that will require allogeneic or autologous transplantation following pomalidomide dexamethasone treatment while in the same course.
2.Any other uncontrolled medical condition or comorbidity that might interfere with subject’s participation
3.Pregnant or breast feeding females
4.Use of any other experimental drug or therapy within 15 days of screening.
5.Patients with renal failure that require dialysis and patients with creatinine clairance < 50 mL/min
6.Known positive for HIV or active infectious hepatitis type B or C.
7.Patients with non-secretory MM (non measurable)
8. Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for =3 years.9.Prior local irradiation within two weeks before screening
10.Evidence of central nervous system (CNS) involvement
11.Any >grade 2 toxicity unresolved
12.Peripheral neuropathy > Grade 2
13.Known Hypersensitivity to Thalidomide, Lenalidomide
14.Ongoing active infection, especially ongoing pneumonytis
15.Ongoing Cardiac dysfunction
16.Inability or unwillingness to comply with birth control requirements
17.Unable to take antithrombotic medicines at study entry
18.Unable to take dexamethasone at study entry
19.Refusal to participate in the study
20.Persons protected by a legal regime (guardianship, trusteeship)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified