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Study of Fluphenazine in Relapsed or Relapsed-and-Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Immune Control

Tracking Information
First Submitted Date  ICMJE January 9, 2009
First Posted Date  ICMJE January 13, 2009
Last Update Posted Date January 13, 2009
Study Start Date  ICMJE December 2008
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
Tolerability of fluphenazine. [ Time Frame: 21 day treatment cycle(s) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
Changes in serum and urine M-protein or free light chain concentrations determined using protein electrophoresis. [ Time Frame: 21 day treatment cycle(s) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of Fluphenazine in Relapsed or Relapsed-and-Refractory Multiple Myeloma
Official Title  ICMJE Phase 1b Single Arm, Open Label, Multi-Center Study of Fluphenazine HCl Monotherapy in Relapsed or Relapsed-and-Refractory Multiple Myeloma
Brief Summary The purpose of this study is to evaluate the safety and tolerability of fluphenazine in patients with advanced multiple myeloma. The study will also describe the efficacy of this drug.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 12, 2009)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2010
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of multiple myeloma that is relapsed or relapsed-and-refractory after at least 2 or more prior lines of therapy. Patients must have achieved at least minor response (MR) to at least one prior line of therapy
  • Progressive disease must have occurred either during or subsequent to the patient's last treatment for multiple myeloma prior to the current enrollment
  • Measurable disease defined by serum M-protein ≥1 g/dL, or urine light chain ≥200 mg/24 hours, or abnormal serum FLC ratio with involved FLC > 10 mg/dL provided serum FLC ratio is abnormal
  • Age >18 years
  • Eastern Cooperative Oncology Group (performance status of ≤20
  • Life expectancy ≥12 weeks
  • Signed written informed consent per institutional and federal regulatory requirements
  • Did not receive chemotherapy (including systemic steroids), immunotherapy (interferon), Imids (thalidomide/lenalidomide), proteasome inhibitors (bortezomib), or radiotherapy for at least 21 days prior to Day 1 of Cycle 1
  • Did not receive any investigational treatment for at least 28 days prior to study entry
  • Absolute granulocyte count of ≥1,000/μL, platelet count ≥50,000/μL, and hemoglobin ≥8.0 g/dL, with no transfusion within the preceding 7 days
  • Adequate liver function defined by a bilirubin value ≤2 times the upper limit of normal (ULN), and transaminases (AST and ALT) values ≤2.5 times ULN
  • Adequate renal function defined by a creatinine clearance of ≥30 mL/min
  • Adequate cardiac function defined by a left ventricular ejection fraction (LVEF) ≥40%, QTc <450 msec, and no evidence of clinically significant dysrhythmias on ECG
  • Patient must have substantially recovered from clinically significant toxicities from prior therapies for multiple myeloma
  • Fertile men and women must agree to use a medically effective contraception method throughout the treatment period. Premenopausal women of reproductive capacity and women less than 24 months post menopause must have a negative serum pregnancy test documented prior to study entry

Exclusion Criteria:

  • Patients who never achieved at least minor response (MR) to at least one prior line of therapy
  • Clinical spinal cord compression syndromes (unless patient has undergone treatment, for example, surgery or radiation therapy, and neurological findings are ≤ Grade 1 and patient is off corticosteroids for spinal cord edema or on a stable regimen of < 10 mg/day prednisone equivalent
  • Clinical signs of brain involvement or leptomeningeal disease
  • Plasma cell leukemia (plasma cells > 2000/cubic mm)
  • Women who are pregnant or breast feeding
  • Other serious illness or medical condition(s) (see protocol)
  • Hypersensitivity to fluphenazine or other phenothiazines
  • Currently being treated with hematopoietic growth factors other than erythropoietin (EPO). Treatment with hematopoietic growth factors may be started during the study with development, or worsening, of cytopenia
  • Concurrent use of anticholinergics
  • Concurrent use of phenothiazine and atypical antipsychotics
  • Concurrent use of anti-seizure drugs, with the exception of gabapentin for treatment of neuropathy
  • Grade 2 or higher persisting prior treatment-related neuropathy
  • Concurrent use of systemic steroids with the exception of chronically administered steroids equivalent to ≤ 10 mg/day prednisone if patient has been on this therapy for ≥1month
  • History of seizures or extrapyramidal symptoms
  • History of other malignancies within the past 3 years, other than adequately treated non-melanoma skin cancer, or in situ carcinoma of the cervix, unless the other malignancy is quiescent and medical monitor approval is obtained
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00821301
Other Study ID Numbers  ICMJE FM-CL2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen Roth, Ph.D., Immune Control Inc.
Study Sponsor  ICMJE Immune Control
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bruce A Silver, M.D., FACP
PRS Account Immune Control
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP