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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT01745640
• Date of registration: 29/10/2012
• Prospective Registration: No
• Primary sponsor: University Hospital, Lille
• Public title: Pomalidomide and Dexamethasone Effects in Multiple Myeloma Patients With Del 17p or t (4;14) IFM2010-02
• Scientific title: 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-IFM2010-02
• Date of first enrolment: January 2012
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01745640
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Xavier LELEU, PHD
• Affiliation: CHRU de Lille

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: POMALIDOMIDE

Drug: Dexamethasone

Primary Outcome(s)

Time to disease progression (from the date of the first dose to the date of the first observation of disease progression) [Time Frame: The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months ).]

Secondary Outcome(s)

Overall Survival of pomalidomide and dexamethasone and event free survival [Time Frame: The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ).]

Safety of pomalidomide and dexamethasone [Time Frame: for the first 15 patients included at time they end cycle 1 (an expected average of 6 months from the first inclusion)]

Time to response and Response duration of pomalidomide and dexamethasone. [Time Frame: The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ).]

Response and Time to disease progression with regards to cytogenetic abnormalities in the bone marrow tumor plasma cells [Time Frame: The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ).]

Overall Response rate (Partial Response and better), Very Good Partial Response (VGPR) + Complete Response (CR) rate and stringent Complete Response (sCR) rate to pomalidomide and dexamethasone in MM patients [Time Frame: The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ).]

Secondary ID(s)

2010_52

2011-002081-20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Celgene Corporation