An Expanded Treatment Protocol of Panobinostat in Combination Therapy for Relapsed, and Relapsed and Refractory Multiple Myeloma

NCT02568943 | Unknown

• 1 other identifier: CLBH589D2001X
• Study Type: expanded_access
• Target: N/A
• Locations: 6 countries
• Sites: 40

Brief Summary

The purpose of this study is to provide oral panobinostat (PAN) treatment to relapsed or relapsed and refractory multiple myeloma patients who are without satisfactory treatment alternatives prior to the commercial availability\* and reimbursement of panobinostat during the regulatory approval process. This protocol will acquire additional safety data on the use of panobinostat in combination with bortezomib (BTZ) and dexamethasone (Dex) in patients with relapsed or relapsed and refractory multiple myeloma. In this protocol, PAN must be administered in the defined regimen in combination with both BTZ and DEX. \*(Note: throughout this protocol "commercially available" means local health authority approval and a functional method for reimbursement)

Conditions

Multiple Myeloma

Keywords

multiple myelome, MM, expanded treatment, panobinostat, bortezomib, dexamethasone, relapsed, refractory, LBH589

Interventions

Panobinostat DRUG

Panobinostat (PAN \[LBH589\]) is an orally administered pan-deacetylase inhibitor (DACi) belonging to a structurally novel class of compounds deregulating cell proliferation and survival mechanisms of cancer cells.

Also known as: LBH589

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Written informed consent must be obtained prior to any screening procedures
• \. Patient's age is ≥ 18 years at the time of signing informed consent
• \. Patient has a previous diagnosis of multiple myeloma, based on IMWG 2014 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)
• \. Patient with multiple myeloma (Palumbo 2014) that is relapsed or relapsed and refractory to at least twoone prior lines of therapy and requires retreatment.
• Relapsed, defined by disease that recurred in a patient that responded under at least two prior therapiesy, by reaching a MR or better, and had not progressed under current therapy or up to 60 days of last dose of this therapy. Patients previously treated with bortezomib are eligible.
• Relapsed-and-refractory to a therapy, provided that patient meets both conditions:
• patient has relapsed to at least twoone prior lines
• and patient was refractory to at least twoone prior lines by either not reaching a MR, or progressed while under this therapy, or within 60 days of its last dose. Patients previously treated with bortezomib are eligible even if they are deemed refractory (based on results on Panorama 2)
• Patients who have previously received high dose therapy/autologous stem cell transplant are eligible.
• Patients who have undergone allogeneic stem cell transplant and do not have active graft vs host disease requiring immunosuppressive therapy are eligible.
• \. Patient has measurable disease at study screening defined by IMWG 2014 criteria (Palumbo 2014))
• \. A patient treated with local radiotherapy with or without concomitant exposure to steroids for pain control or management of cord/nerve root compression is eligible. Four weeks should have lapsed since last date of radiotherapy, which is recommended to be a limited field. Patients who require concurrent radiotherapy should have entry to the study deferred until the radiotherapy is completed and 2 weeks have passed since the last date of therapy.

You may not qualify if:

• Patients eligible for this study must not meet any of the following criteria:
• \. Patient has shown intolerance to bortezomib, dexamethasone or panobinostat or components of these drugs or has any contraindications to any of these therapies following locally applicable prescribing information.
• \. Patient is refractory to panobinostat
• \. Allogeneic stem cell transplant recipient presenting with graft versus host disease either active or requiring immunosuppression
• \. Patient has grade ≥ 2 peripheral neuropathy
• \. Patient taking any anti-cancer therapy concomitantly (bisphosphonates are permitted)
• \. Patient has second primary malignancy \< 3 years of first dose of study treatment (except for adequately treated basal or squamous cell carcinoma, or in situ cancer of the cervix)
• \. Patient who received:
• Anti-myeloma chemotherapy or medication including IMiDs, proteasome inhibitor, and dexamethasone ≤3weeks prior to the start of study
• Experimental therapy or biologic immunotherapy including monoclonal antibodies ≤ 4 weeks prior to the start of study
• Prior radiation therapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to the start of study
• \. Patient has not recovered from all therapy-related toxicities associated with above listed treatments to \< grade 2 CTCAE
• \. Patient has undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects to such therapy to \< grade 2 CTCAE
• \. Patient with evidence of mucosal or internal bleeding
• \. Patient has unresolved diarrhea ≥ CTCAE grade 2

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (40)

Novartis Investigative Site

Innsbruck, Tyrol, 6020, Austria

Location

Novartis Investigative Site

Linz, A-4010, Austria

Location

Novartis Investigative Site

Rankweil, A-6830, Austria

Location

Novartis Investigative Site

Salzburg, 5020, Austria

Location

Novartis Investigative Site

Vienna, 1140, Austria

Location

Novartis Investigative Site

Vienna, A-1090, Austria

Location

Novartis Investigative Site

Kitchener, Ontario, N2G 1G3, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H4J 1C5, Canada

Location

Novartis Investigative Site

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, 68305, Germany

Location

Novartis Investigative Site

Bad Saarow, 15526, Germany

Location

Novartis Investigative Site

Bamberg, 96049, Germany

Location

Novartis Investigative Site

Bayreuth, 95445, Germany

Location

Novartis Investigative Site

Bielefeld, 33604, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Bremen, 28177, Germany

Location

Novartis Investigative Site

Chemnitz, 09113, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Greifswald, 17475, Germany

Location

Novartis Investigative Site

Hamburg, 22763, Germany

Location

Novartis Investigative Site

Hanover, 30449, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Jena, 07740, Germany

Location

Novartis Investigative Site

Karlsruhe, 76133, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Magdeburg, 39120, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

Mutlangen, 73557, Germany

Location

Novartis Investigative Site

München, 81737, Germany

Location

Novartis Investigative Site

Nuremberg, 90419, Germany

Location

Novartis Investigative Site

Rostock, 18057, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Winnenden, 71364, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

Novartis Investigative Site

Amman, 11941, Jordan

Location

Novartis Investigative Site

Oslo, NO-0424, Norway

Location

Novartis Investigative Site

Trondheim, 7006, Norway

Location

Novartis Investigative Site

Linköping, SE 581 85, Sweden

Location

Novartis Investigative Site

Stockholm, 14186, Sweden

Location

Novartis Investigative Site

Umeå, 901 85, Sweden

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 6, 2015
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

DE (25); JO (1); AU (6); NO (2); CA (3); SE (3)