Effect of AT7519M Alone and AT7519M Plus Bortezomib in Patients With Previously Treated Multiple Myeloma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

December 31, 2014

Study Completion Date

March 31, 2015

Conditions
Multiple Myeloma
Interventions
DRUG

AT7519M

"Part A: Nine patients will receive AT7519M as an intravenous infusion on days 1, 4, 8 and 11 of a three week cycle. The starting dose of AT7519M will be 21mg/m\^2/dose and will be increased to 27mg/m\^2/dose during subsequent cycles in the absence of AT7519M-related toxicities.~Part B: Amendment clarified there will be no further exploration of AT7519M as a monotherapy.~Part C: Amendment modified dose escalation to a conventional 3 + 3 design with a maximum total of 14 patients will be treated at the maximum tolerated dose."

DRUG

Bortezomib

Part C will treat between 3-26 patients with a combination of bortezomib and AT7519M in a dose escalation design. The starting doses for the dose escalation are bortezomib 1 mg/m2 and AT7519M 14 mg/m2.

Trial Locations (5)

10065

Memorial Sloan-Kettering Cancer Centre, New York

53226

MCW and Froedtert Clinical Cancer Center, Division of Neoplastic Diseases & Related Disorders, Milwaukee

02215

Beth Israel Deaconess Medical Center, Boston

MA02115

Massachusetts General Hospital, Boston

Unknown

Dana Faber Cancer Institute, Boston

Sponsors
All Listed Sponsors
collaborator

Multiple Myeloma Research Consortium

NETWORK

lead

Astex Pharmaceuticals, Inc.

INDUSTRY