An Open-label, Multi-center, Phase I-Ib/II Study of AUY922 Administered as Single Agent and in Combination With Bortezomib With or Without Dexamethasone in Adult Patients in Relapse or Refractory Multiple Myeloma.
- Patients must have a diagnosis of active multiple myeloma.
- Phase I and Phase II part: Patients must have received at least 2 but not more than
4 prior line of therapy and their disease has progressed during or after last
- Phase Ib part: Patients must have received no more than 2 prior lines of therapy
(excluding dexamethasone as single agent).
- ECOG Performance Status of ≤ 2.
- Patients must have acceptable neutrophil and platelet counts as well as adequate
kidney and liver function.
- Patients must have magnesium levels above lower limit of normal or correctable with
- Patients must be willing and able to undergo bone marrow biopsy/aspirate.
- Able to sign informed consent.
- Prior treatment with any HSP90 or HDAC inhibitor for the treatment of multiple
- Patients with unresolved diarrhea ≥ CTCAE grade 2.
- Patients with acute or chronic liver disease.
- Patients using medications that have a relative risk of prolonging the QT interval.
- Clinically significant cardiac diseases.
- Patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g.
- Pregnant or lactating women.
- Fertile women of childbearing potential (WCBP) not using adequate contraception.
- Male patients whose partners are WCBP, not using adequate contraception.
- Patients who unwilling or unable to comply with the protocol.
- Phase Ib part: Peripheral neuropathy ≥ CTCAE grade 1.
- Phase Ib part: Prior treatment with bortezomib.
Other protocol-defined inclusion/exclusion criteria may apply