Status:
NO_LONGER_AVAILABLE
Expanded Treatment Prot of Panobinostat in Combo w/ Bortez and Dex in Pts w/ Relapsed and/or Refractory Multiple Myeloma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
This will be a multi-center, open label, expanded treatment protocol of panobinostat, bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma. Panobinostat will be ad...
Eligibility Criteria
Inclusion
- This study is intended for patients with relapsed and/or refractory multiple myeloma, who have received at least one prior line of therapy. Patients must require retreatment as per IMWG definitions (Kyle et al 2003). Approximately 50-100 patients are expected to be enrolled into this trial.
- Patient has a previous diagnosis of multiple myeloma, based on IMWG 2003 definitions all three of the following criteria had been met:
- Monoclonal immunoglobulin (M component) on electrophoresis, and on immunofixation on serum or on total 24 hour urine (or demonstration of M protein in cytoplasm of plasma cell for non secretory myeloma).
- Bone marrow (clonal) plasma cells ≥ 10% or biopsy proven plasmacytoma
- Related organ or tissue impairment (CRAB symptoms: anemia, hypercalcemia, lytic bone lesions, renal insufficiency, hyperviscosity, amyloidosis or recurrent infections)
- Patients who have received allogeneic stem cell transplant and do not have active graft vs host disease requiring immunosuppressive therapy are eligible.
- Patient with multiple myeloma (per IMWG 2003 definition) that is relapsed and/or refractory to at least one prior line of therapy and requires retreatment
- Relapsed-and-refractory to a therapy, provided that the patient meets any of the following conditions:
- Relapsed, defined by disease that recurred in a patient that responded under a prior therapy, by reaching a MR or better, and had not progressed under this therapy nor up to 60 days of last dose of this therapy. Patients who previously responded to treatment with BTZ are eligible.
- Patient has relapsed to at least one prior line and patient was refractory to at least one prior line by either not reaching a MR, or progressed while under this therapy, or within 60 days of its last dose. Patients previously refractory to BTZ are also eligible.
- Patients with primary refractory disease are eligible.
- Patients who have previously received high dose therapy/autologous stem cell transplant are eligible
- Patients who have received allogeneic stem cell transplant and do not have active graft vs host disease requiring immunosuppressive therapy are eligible
Exclusion
- Patient has shown intolerance to bortezomib, dexamethasone or panobinostat or has any contraindications to any of these therapies. following available prescribing information
- Allogeneic stem cell transplant recipient presenting with graft versus host disease either active or requiring immunosuppression
- Patient has grade ≥ 2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination within 14 days of treatment
- Patient taking any anti-cancer therapy concomitantly
- Patient has second primary malignancy \< 3 years of first dose of study treatment (except for treated basal or squamous cell carcinoma, or in situ cancer of the cervix)
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02204553
Last Update
January 5 2016
Active Locations (27)
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1
Ironwood Cancer and Research Centers Ironwood Cancer
Chandler, Arizona, United States, 85224
2
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
3
Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C
Anaheim, California, United States, 92807
4
Alta Bates Cancer Center
Berkeley, California, United States, 94704