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A Phase I-Ib/II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 Alone and in Combination With Bortezomib, With or Without Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00708292
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : July 22, 2015
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is a Phase I-Ib/II, open-label, multicenter study of AUY922 administered intravenously in patients with multiple myeloma to determine the maximum tolerated dose. The Phase II part will investigate the efficacy of AUY922 in patients with multiple myeloma. Additionally, the study includes a Phase Ib combination part of AUY922 administered in combination with bortezomib, to determine the maximum tolerated dose of the combination drugs in patients with multiple myeloma.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Drug: AUY922 Drug: Bortezomib Drug: Dexamethasone Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: Single Agent AUY922 Drug: AUY922
Experimental: AUY922 + Bortezomib Drug: AUY922
Drug: Bortezomib
Experimental: AUY922 + Bortezomib + Dexamethasone Drug: AUY922
Drug: Bortezomib
Drug: Dexamethasone

Primary Outcome Measures :
  1. The safe dose of AUY922 when administered once a week. [ Time Frame: 54 weeks (Maximum Tolerated Dose (MTD)) ]

Secondary Outcome Measures :
  1. The safe dose of AUY922 when administered once a week in combination with bortezomib and dexamethasone. [ Time Frame: 24 weeks (MTD determination of dual and triple combination) ]
  2. Efficacy of AUY922 administered once a week alone and in combination [ Time Frame: at baseline and every 2 cycles (time to document tumor progression) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00708292

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United States, Arizona
Mayo Clinic - Arizona Cancer Clinical Research Unit
Scottsdale, Arizona, United States, 85259
United States, Texas
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(3)
San Antonio, Texas, United States, 78229
Novartis Investigative Site
Melbourne, Australia, 3004
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
München, Germany, 81675
Novartis Investigative Site
Wuerzburg, Germany, 97070
Novartis Investigative Site
Singapore, Singapore, 169608
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site
Madrid, Spain, 28006
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00708292    
Other Study ID Numbers: CAUY922A2103
2007-006279-35 ( EudraCT Number )
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: June 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple Myeloma
HSP90 inhibitors
Phase I/II
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors