Expanded Treatment Prot of Panobinostat in Combo w/ Bortez and Dex in Pts w/ Relapsed and/or Refractory Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma, Panobinostat, LBH589, Expanded Access, EAP, ETP, Expanded Treatment, Bortezomib, HDAC, histone deacetylace inhibitor
Study Type
Expanded Access
Study Phase
N/A
Study Design
N/A
Intervention
Name: Panobinostat
Type: Drug
Overall Status
Available
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 administered at a starting dose of 20mg orally three times a week (every other day) for two weeks on and one week off, with dose adjustments permitted based on observed toxicity. Bortezomib will be administered either intravenously or sub-cutaneously, twice a week on days 1 and 4, two weeks on 1 week off. After 8 cycles of treatment, patients who have achieved stable disease or better by modified EBMT 1998 criteria may continue combination therapy with bortezomib dosing changed to days 1 and 8 of a 21 day cycle for up to 48 weeks of therapy. At the end of the treatment period, (48 weeks) patients with stable disease or better may continue on therapy at the discretion of their investigator until September 2015 or until drug is commercially available, whichever comes first. Patients who have not achieved at least stable disease by 8 cycles must discontinue from study treatment. Dexamethasone will be administered on the day of and the day immediately following bortezomib treatment. Patients will not receive any study treatment during the third week of each cycle. Cycles will be defined as 21 days of treatment. Investigators may not add any other anti-myeloma agents (with the exception of bisphosphonates) while patients remain on study treatment. Patients will remain on study until disease progression, unacceptable toxicity, or end of the study
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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 Criteria:

- 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)
Locations
Ironwood Cancer and Research Centers Ironwood Cancer
Chandler, Arizona, United States
Status:
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States
Status:
Contact: - 479-872-8130
Kaiser Permanente Medical Group Kaiser Permanente - Moanalua
Anaheim, California, United States
Status:
Contact: - 808-432-8587
Alta Bates Cancer Center
Berkeley, California, United States
Status:
Contact: - 510-204-3428
Los Angeles Hematology/Oncology Medical Group
Los Angeles, California, United States
Status:
Contact: - 213-977-1214
Stanford Cancer Center Stanford Cancer Institute (2)
Stanford, California, United States
Status:
Contact: - 650-723-4000
George Washington U Medical Center Medical Faculty Associates
Washington, District of Columbia, United States
Status:
Contact: - 202-741-2478
University Cancer Institute Univ. Cancer Institute
Boyton Beach, Florida, United States
Status:
Contact: - +1 561 737 6556
Memorial Cancer Institute Memorial Cancer Inst.
Hollywod, Florida, United States
Status:
Contact: - (954) 844-9720
Lakes Research SC
Miami Lakes, Florida, United States
Status:
Emory University School of Medicine/Winship Cancer Institute Winship Cancer Institute (2)
Atlanta, Georgia, United States
Status:
Contact: - 404-778-5144
Stormont-Vail Cancer Center
Topeka, Kansas, United States
Status:
Contact: - 785-354-5300
Hematology Oncology Clinic Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
Status:
Sinai Hospital of Baltimore Sinai Hospital, Baltimore
Baltimore, Maryland, United States
Status:
Contact: - 410-601-5961
Bronson Battle Creek Cancer Care Center
Battle Creek, Michigan, United States
Status:
Contact: - 269-245-8359
University of Mississippi Medical Center Cancer Institute
Jackson, Mississippi, United States
Status:
Contact: - 601-984-5615
Research Medical Center Research Med. Center
Kansas City, Missouri, United States
Status:
Contact: - 816-276-4700
Oncology Hematology West, PC Nebraska Cancer Specialists
Omaha, Nebraska, United States
Status:
Contact: - 402-334-4773
Hematology Oncology of Central New Jersey
Little Silver, New Jersey, United States
Status:
Contact: - 732-530-8666
Morton Coleman, MD M. Coleman, MD (2)
New York, New York, United States
Status:
Contact: - 212-517-5900
Cancer Centers of the Carolinas GHS Cancer Institute
Greenville, South Carolina, United States
Status:
Contact: - 864-987-7000
Wellmont Medical Associates
Bristol, Tennessee, United States
Status:
Contact: - 423-968-2311
Texas Oncology Texas Oncology - Arlington
Dallas, Texas, United States
Status:
Contact: - 817-664-9600
Texas Oncology TX Oncology Baylor
Dallas, Texas, United States
Status:
Contact: - +1 214 370 1000
Northern Utah Cancer Associates SC
Ogden, Utah, United States
Status:
Contact: - 801-387-7166
Virginia Oncology Associates Virginia Oncology Assoc. (2)
Norfolk, Virginia, United States
Status:
Contact: - 757-213-5658
Fox Valley Hematology and Oncology
Appleton, Wisconsin, United States
Status:
Contact: - 920-730-5379
Sponsors
Novartis Pharmaceuticals
Source
Novartis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page