An Open Label, International, Multi-Center, Phase I/IIA Study of Lenalidomide (Revlimid) and Romidepsin (Istodax) for Relapsed/Refractory Hodgkin Lymphoma, Mature T-Cell Lymphoma and Multiple Myeloma (RID Study)
Trial Purpose and Description
- To establish DLTs and an MTD for the combination of romidepsin and lenalidomide for patients with lymphoma; and of romidepsin, lenalidomide and dexamethasone for patients with myeloma.
- To establish tolerability and feasibility at the recommended phase-II doses for the combination regimens.
- To establish initial evidence of efficacy in each of the three treatment groups according to histological diagnosis.
- To explore the immunological, histological and gene-expression correlates of disease response and drug toxicity.
- Mature T-Cell lymphoma- PTCL or CTCL (including MF and SS) but excluding adult T-cell leukemia/lymphoma,primary cutaneous CD30+ lymphoma,lymphomatoid papulosis,and NK or LGL leukemia.(The complete WHO classification ofT-cell lymphoma can be found in the appendices).
- Peripheral T-celllymphoma: patients must have relapsed or progressed after: at least one prior chemotherapy-based treatment,or not suitable for a conventional chemotherapeutic approach as judged by the investigator.
- Sezary syndrome/ Mycosis Fungoides: patients must have relapsed or progressed after at least one prior systemic therapy.
- Hodgkin lymphoma- At least one prior chemotherapy-based treatment. Prior autograft in those eligible for autologous transplantation according to institutional guidelines.
- Myeloma- Relapsed after at least one prior systemic therapy that includes thalidomide (unless intolerant or contraindicated) or lenalidomide. Those who have received prior lenalidomide must have had a response that exceeded 6 months.
- Age >18 years.
- Life expectancy >90 days.
- Patients receiving any other investigational agents within 4 weeks.
- Prior exposure to lenalidomide,in patients with myeloma,except if a response (including stable disease) was maintained for at least 6 months. (Washout period of 4 weeks required)
- Concomitant treatment with sodium valproate (washout 4 weeks required).
- Central nervous system involvement by lymphoma or myeloma.
- A history of allergic reaction to romidepsin or lenalidomide,boron or mannitol.
- A history of Gr III/IV drug-related non-hematological toxicity,excluding thromboembolism or sepsis,in a prior exposure to either lenalidomide or a histone deacetylase inhibitor.
- Patients who have active coronary artery disease (for example NYHA class II or above angina). Any patient in whom coronary artery disease is suspected should be referred for a cardiology consultation and if active myocardial ischemia is demonstrated, the patient should be excluded. If a non-invasive imaging study is equivocal, it may be necessary to proceed to coronary angiography
- Patients with a history of sustained VT,VF,torsade de pointes or cardiac arrest unless that issue is currently managed with an implantable cardioverter defibrillator (AICD).
- Celgene Corporation
- Yale Cancer Center
- Last Updated:
- Study HIC#: