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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.


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Relapsed or Refractory Multiple Myeloma

Thank you

Trial Information

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.

Inclusion Criteria


Inclusion criteria:

- 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
therapy.

- 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
supplements.

- Patients must be willing and able to undergo bone marrow biopsy/aspirate.

- Able to sign informed consent.

Exclusion criteria:

- Prior treatment with any HSP90 or HDAC inhibitor for the treatment of multiple
myeloma.

- 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.
Gilbert's syndrome).

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The safe dose of AUY922 when administered once a week.

Outcome Time Frame:

54 weeks (Maximum Tolerated Dose (MTD))

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAUY922A2103

NCT ID:

NCT00708292

Start Date:

July 2008

Completion Date:

January 2011

Related Keywords:

  • Relapsed or Refractory Multiple Myeloma
  • AUY922
  • Multiple Myeloma
  • HSP90 inhibitors
  • Phase I/II
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(3) San Antonio, Texas  78229
Mayo Clinic - Arizona Cancer Clinical Research Unit Scottsdale, Arizona  85259