Clinical trial · Interventional
Pomalidomide and Dexamethasone Effects in Multiple Myeloma Patients With Del 17p or t (4;14)
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
NCT01745640CI-TRIAL-00102560IFM2010-02completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| POMALIDOMIDE | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- POMALIDOMIDE and dexamethasone treatment
- description
- All patients will receive pomalidomide (4 mg/day per os) and dexamethasone (40/20 mg/wk per os) during 21 day/28 day cycle
- interventionNames
- Drug: POMALIDOMIDE
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Time to disease progression (from the date of the first dose to the date of the first observation of disease progression)
- timeFrame
- The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months ).
- description
- The time to progression (TTP) is the time from the start of treatment to the first documentation of disease progression or death from any cause during study, whichever occurs earlier.The Kaplan-Meier procedures will be used to characterize the time-to-event curves (TTP, OS, response duration and EFS) when there is censoring; univariate summary statistics will be provided for time to response.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTLeleu X, Karlin L, Macro M, Hulin C, Garderet L, Roussel M, Arnulf B, Pegourie B, Kolb B, Stoppa AM, Brechiniac S, Marit G, Thielemans B, Onraed B, Mathiot C, Banos A, Lacotte L, Tiab M, Dib M, Fuzibet JG, Petillon MO, Rodon P, Wetterwald M, Royer B, Legros L, Benboubker L, Decaux O, Escoffre-Barbe M, Caillot D, Fermand JP, Moreau P, Attal M, Avet-Loiseau H, Facon T; Intergroupe Francophone du Myelome (IFM). Pomalidomide plus low-dose dexamethasone in multiple myeloma with deletion 17p and/or translocation (4;14): IFM 2010-02 trial results. Blood. 2015 Feb 26;125(9):1411-7. doi: 10.1182/blood-2014-11-612069. Epub 2015 Jan 9. PMID 25575538