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Spots Global Cancer Trial Database for Phase I Bortezomib (VELCADE) in Combo With Pralatrexate in Relapsed/Refractory MM

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Trial Identification

Brief Title: Phase I Bortezomib (VELCADE) in Combo With Pralatrexate in Relapsed/Refractory MM

Official Title: A Phase I Study of Bortezomib (VELCADE) in Combination With Pralatrexate in Relapsed/Refractory Multiple Myeloma

Study ID: NCT01114282

Interventions

velcade
Pralatrexate

Study Description

Brief Summary: The purpose of this trial is to find out the maximum tolerated dose (MTD) of bortezomib (VELCADE) in combination with pralatrexate in patients with previously treated multiple myeloma, AL amyloid and Waldenstroem's macroglobulinemia.

Detailed Description: This is an open-label Phase I dose-escalation safety study of VELCADE in combination with pralatrexate in patients with previously treated multiple myeloma. In a standard 3+3 dose escalation trial design, escalating doses of pralatrexate in combination with VELCADE will be studied sequentially, with at least 3 patients in each dose level until the MTD is determined. Dose limiting toxicity (DLT) and MTD are determined during cycle 1 of treatment.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Stanford University School of Medicine, Stanford, California, United States

Contact Details

Name: Michaela Liedtke

Affiliation: Stanford University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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