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.

December 11, 2020 updated by: Novartis Pharmaceuticals

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Agent AUY922
Drug: AUY922
Experimental: AUY922 + Bortezomib
Drug: Bortezomib
Drug: AUY922
Experimental: AUY922 + Bortezomib + Dexamethasone
Drug: Dexamethasone
Drug: Bortezomib
Drug: AUY922

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The safe dose of AUY922 when administered once a week.
Time Frame: 54 weeks (Maximum Tolerated Dose (MTD))
54 weeks (Maximum Tolerated Dose (MTD))

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
24 weeks (MTD determination of dual and triple combination)
Efficacy of AUY922 administered once a week alone and in combination
Time Frame: at baseline and every 2 cycles (time to document tumor progression)
at baseline and every 2 cycles (time to document tumor progression)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

July 1, 2008

First Posted (Estimate)

July 2, 2008

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAUY922A2103
  • 2007-006279-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe