Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Myeloma

In brief

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile. Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

Key facts

Study ID

NCT01023308

Run by

Novartis Pharmaceuticals

People needed

767

Starts

2009-12-21

Expected to finish

2015-07-30

Last updated by the study team

2020-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has a previous diagnosis of multiple myeloma.
• Patient requires retreatment for multiple myeloma
• Patient has measurable M component in serum or urine at study screening

You may not qualify if…

• Patient who has progressed under all prior lines of anti MM therapy
• Patient who has been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose
• Patient has shown intolerance to bortezomib or to dexamethasone or components of these drugs or has any contraindication to one or the other drug , following locally applicable prescribing information
• Patient received prior treatment with DAC inhibitors including panobinostat
• Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG
• Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pointes
• Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Anaheim, California, United States
• Novartis Investigative Site — Concord, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Stanford, California, United States
• Novartis Investigative Site — Boca Raton, Florida, United States
• Novartis Investigative Site — Lake Worth, Florida, United States
• Novartis Investigative Site — Miami Shores, Florida, United States
• Novartis Investigative Site — Athens, Georgia, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Marietta, Georgia, United States
• Novartis Investigative Site — Marywood, Illinois, United States
• Novartis Investigative Site — Quincy, Illinois, United States
• Novartis Investigative Site — New Orleans, Louisiana, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Rockville, Maryland, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Southfield, Michigan, United States
• Novartis Investigative Site — Edina, Minnesota, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Columbia, Missouri, United States
• Novartis Investigative Site — East Orange, New Jersey, United States
• Novartis Investigative Site — Mount Kisco, New York, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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