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A Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib (Flu-Mel-Vel)

This study is currently recruiting participants.
Verified May 2013 by Hackensack University Medical Center
Sponsor:
Information provided by (Responsible Party):
Hackensack University Medical Center
ClinicalTrials.gov Identifier:
NCT01453101
First received: October 13, 2011
Last updated: May 10, 2013
Last verified: May 2013
History of Changes

October 13, 2011
May 10, 2013
May 2010
May 2013   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The main primary endpoint of this study is two-year progression free survival. Patients are considered a failure with respect to PFS if they die or experience disease progression or relapse. The time to this event is the time from transplantation to relapse/progression, initiation of non-protocol anti-myeloma therapy, or death from any cause. Subjects alive without confirmed disease progression will be censored at the time of last disease evaluation. Deaths without progression are treated as failures no matter when they occur.
Same as current
Complete list of historical versions of study NCT01453101 on ClinicalTrials.gov Archive Site
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Not Provided
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A Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib
A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib

The hypothesis for this study is that the regimen consisting of fludarabine, melphalan and bortezomib improves the progression free survival and the response rate compared to historical controls of fludarabine and melphalan alone.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: Fludarabine monophosphate, melphalan, Bortezomib
  • Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5.
  • Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2
  • Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan.
Fludarabine, Melphalan, Bortezomib
Intervention: Drug: Fludarabine monophosphate, melphalan, Bortezomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55
May 2014
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of multiple myeloma
  • Have a suitable related or unrelated donor
  • Age ≥18 but <70 yrs
  • KPS of ≥70%
  • Recovery from complications of previous therapies

Exclusion Criteria:

  • Diagnosis other than multiple myeloma
  • Chemotherapy or radiotherapy within 21 days of initiating treatment in this study
  • Prior dose-intense therapy requiring HSC support within 56 days of initiating treatment in this study
  • Uncontrolled bacterial, viral, fungal or parasitic infections
  • Uncontrolled CNS metastases
  • Known amyloid deposition in heart
  • Organ dysfunction
  • LVEF <40% or cardiac failure not responsive to therapy
  • FVC, FEV1, or DLCO <50% of predicted and/or receiving supplementary continuous oxygen
  • Evidence of hepatic synthetic dysfunction, or total bilirubin >2x or AST >3x ULN
  • Measured creatinine clearance <20 ml/min
  • Sensory peripheral neuropathy grade 4 within 14 days of enrollment
  • Karnofsky score <70% unless a result of bone disease directly caused by myeloma
  • Life expectancy limited by another co-morbid illness
  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
  • Female subject is pregnant or breast-feeding (women) or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Documented hypersensitivity to fludarabine or melphalan or to bortezomib, boron or mannitol or any components of the formulation
  • Patients unable or unwilling to provide consent
  • Patient has a sustained platelet count of <30 x 10 9/L within 14 days before enrollment
  • Patient has a sustained absolute neutrophil count of <1.0 x10 9/L within 14 days before enrollment
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant
  • Patient has received other investigational drugs with 14 days before enrollment
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Both
18 Years to 69 Years
No
Contact: Michele Donato, MD 201-996-5000 MDonato@humed.com
Contact: Ann Marie Maguire, RN 551-336-8213 AMaguire@hackensackUMC.org
United States
 
NCT01453101
PRO1261
Yes
Hackensack University Medical Center
Hackensack University Medical Center
Not Provided
Not Provided
Hackensack University Medical Center
May 2013

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