Expanded Treatment Prot of Panobinostat in Combo w/ Bortez and Dex in Pts w/ Relapsed and/or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

An Expanded Treatment Protocol of Panobinostat (LBH589) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma Who Have Had at Least One Prior Line of Therapy

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02204553
• Other study ID #: CLBH589DUS94X
• Status: No longer available
• Phase: N/A
• First received: July 28, 2014
• Last updated: January 4, 2016

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

N/A

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Panobinostat
Treating patients with relapsed and/or refractory Multiple Myeloma

Locations

Country	Name	City	State
United States	Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C	Anaheim	California
United States	Fox Valley Hematology and Oncology	Appleton	Wisconsin
United States	Emory University School of Medicine/Winship Cancer Institute Winship Cancer Institute (2)	Atlanta	Georgia
United States	Sinai Hospital of Baltimore Sinai Hospital, Baltimore	Baltimore	Maryland
United States	Hematology Oncology Clinic Hematology Oncology Clinic	Baton Rouge	Louisiana
United States	Bronson Battle Creek Cancer Care Center	Battle Creek	Michigan
United States	Alta Bates Cancer Center	Berkeley	California
United States	University Cancer Institute Univ. Cancer Institute	Boyton Beach	Florida
United States	Wellmont Medical Associates	Bristol	Tennessee
United States	Ironwood Cancer and Research Centers Ironwood Cancer	Chandler	Arizona
United States	Texas Oncology Texas Oncology - Arlington	Dallas	Texas
United States	Texas Oncology TX Oncology Baylor	Dallas	Texas
United States	Highlands Oncology Group Dept of Highlands Oncology Grp	Fayetteville	Arkansas
United States	Cancer Centers of the Carolinas GHS Cancer Institute	Greenville	South Carolina
United States	Memorial Cancer Institute Memorial Cancer Inst.	Hollywod	Florida
United States	University of Mississippi Medical Center Cancer Institute	Jackson	Mississippi
United States	Research Medical Center Research Med. Center	Kansas City	Missouri
United States	Hematology Oncology of Central New Jersey	Little Silver	New Jersey
United States	Los Angeles Hematology/Oncology Medical Group	Los Angeles	California
United States	Lakes Research SC	Miami Lakes	Florida
United States	Morton Coleman, MD M. Coleman, MD (2)	New York	New York
United States	Virginia Oncology Associates Virginia Oncology Assoc. (2)	Norfolk	Virginia
United States	Northern Utah Cancer Associates SC	Ogden	Utah
United States	Oncology Hematology West, PC Nebraska Cancer Specialists	Omaha	Nebraska
United States	Stanford Cancer Center Stanford Cancer Institute (2)	Stanford	California
United States	Stormont-Vail Cancer Center	Topeka	Kansas
United States	George Washington U Medical Center Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States,