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.

Phase 1

Completed

• Conditions: Relapsed or Refractory Multiple Myeloma
• Interventions: Drug: AUY922; Drug: Bortezomib; Drug: Dexamethasone

• Registration Number: NCT00708292
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-27
• Study Start: 2008-07
• Study First Submitted QC: 2008-07-01
• Study First Posted: 2008-07-02
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Disposition First Submitted: 2012-05-01
• Disposition First Submitted QC: 2012-05-01
• Disposition First Posted: 2012-05-03
• Status Verified: 2015-06
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AUY922 + Bortezomib	Bortezomib	-
AUY922 + Bortezomib + Dexamethasone	Dexamethasone	-
AUY922 + Bortezomib + Dexamethasone	Bortezomib	-
Single Agent AUY922	AUY922	-
AUY922 + Bortezomib	AUY922	-
AUY922 + Bortezomib + Dexamethasone	AUY922	-

Primary Outcome Measures

Name	Time	Method
The safe dose of AUY922 when administered once a week.	54 weeks (Maximum Tolerated Dose (MTD))

Secondary Outcome Measures

Name	Time	Method
The safe dose of AUY922 when administered once a week in combination with bortezomib and dexamethasone.	24 weeks (MTD determination of dual and triple combination)
Efficacy of AUY922 administered once a week alone and in combination	at baseline and every 2 cycles (time to document tumor progression)

Trial Locations

Locations (3)

Mayo Clinic - Arizona Cancer Clinical Research Unit; 🇺🇸 Scottsdale, Arizona, United States

Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(3); 🇺🇸 San Antonio, Texas, United States

Novartis Investigative Site; 🇪🇸 Madrid, Spain