Study of Fluphenazine in Relapsed or Relapsed-and-Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00821301|
Recruitment Status : Unknown
Verified January 2009 by Immune Control.
Recruitment status was: Recruiting
First Posted : January 13, 2009
Last Update Posted : January 13, 2009
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Fluphenazine HCl||Phase 1|
This is a multicenter, dose-escalating, Phase 1b trial in patients with relapsed or relapsed-and-refractory multiple myeloma. Patients will be dosed on Days 1 and 8 of each 21 day cycle.
This study will be conducted in two parts. In Part 1, the MTD determining portion of the study, patients will be enrolled in cohorts of 3 patients at each dose level. At least 3 patients will complete 21 days at each dose level and will be evaluated for safety and tolerability before additional patients are treated at higher doses. Doses will be increased following a modified Fibonacci scheme.
In Part 2, twelve additional patients will be enrolled at the MTD determined in Part 1 (or the dose for the highest dose cohort completed if the MTD has not been reached) to further evaluate the safety, tolerability, and preliminary efficacy of this dose regimen.
Serum fluphenazine pharmacokinetic studies will be performed during the first cycle of the therapy in all Part 1 and Part 2 consenting patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1b Single Arm, Open Label, Multi-Center Study of Fluphenazine HCl Monotherapy in Relapsed or Relapsed-and-Refractory Multiple Myeloma|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||August 2010|
|Estimated Study Completion Date :||October 2010|
- Drug: Fluphenazine HCl
Fluphenazine HCl will be administered intravenously. To quickly reach and maintain the target bone marrow concentration for 18 hours, the study drug will be administered using 3 bolus injections (0, 6, and 12 hours). Fluphenazine will be dose-escalated according to a modified Fibonacci scheme, terminating in 40% increments. Treatments will be administered on days 1 and 8 of every 21 day cycle.Other Name: Prolixin
- Tolerability of fluphenazine. [ Time Frame: 21 day treatment cycle(s) ]
- Changes in serum and urine M-protein or free light chain concentrations determined using protein electrophoresis. [ Time Frame: 21 day treatment cycle(s) ]
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 ClinicalTrials.gov identifier (NCT number): NCT00821301
|Contact: Stephen Roth, Ph.D.||email@example.com|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Kristine Mykulowycz, RN 215-898-1972 firstname.lastname@example.org|
|Contact: Ed Stadtmauer, MD 215-614-0910 email@example.com|
|Principal Investigator: Ed Stadtmauer, MD|
|University of Pittsburgh Cancer Institute Hillman Cancer Center||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Amy O'Sullivan 412-623-4882 firstname.lastname@example.org|
|Contact: Suzanne Lentzsch, MD 412-648-6586 email@example.com|
|Principal Investigator: Suzanne Lentzsch, MD|
|United States, Texas|
|Cancer Therapy and Research Center at the UT Health Sciences Center at San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Lyanna Smith, BSN, RN 210-450-5816 firstname.lastname@example.org|
|Contact: Swaminathan Padmanabhan, MD 210-450-5882 PadmanabhanS@uthscsa.edu|
|Principal Investigator: Swaminathan Padmanabhan, MD|
|Study Director:||Bruce A Silver, M.D., FACP|