Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma (Flu-Mel-Vel)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Fludarabine monophosphate, melphalan, Bortezomib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib

Resource links provided by NLM:


Further study details as provided by Hackensack University Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 55
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fludarabine, Melphalan, Bortezomib 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.
Other Names:
  • Fludara
  • Phenylalanine Mustard
  • Velcade

Detailed Description:

Multiple myeloma is the second most prevalent blood cancer (10%) after non-hodgkin's lymphoma. It represents approximately 1% of all cancers and 2% of all cancer deaths. Although the peak age of onset of multiple myeloma is 70 years of age, recent statistics indicate both increasing incidence and earlier age of onset.

The historical control 2-year progression-free survival (PFS) is assumed to be 35%. The proposed therapy of fludarabine, melphalan and bortezomib is expected to improve the PFS by 20%.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453101

Contacts
Contact: Michele Donato, MD 201-996-5000 MDonato@humed.com
Contact: Ann Marie Maguire, RN 551-336-8213 AMaguire@hackensackUMC.org

Locations
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Kate Buttner, RN    201-996-5012    KButtner@humed.com   
Contact: Marie Del Favero, RN    201-996-5828    MDelfavero@humed.com   
Principal Investigator: Michele Donato, MD         
Sub-Investigator: Scott D Rowley, MD         
Sub-Investigator: David Siegel, MD, Ph,D         
Sub-Investigator: David Vesole, MD         
Sponsors and Collaborators
Hackensack University Medical Center
  More Information

No publications provided

Responsible Party: Hackensack University Medical Center
ClinicalTrials.gov Identifier: NCT01453101     History of Changes
Other Study ID Numbers: PRO1261
Study First Received: October 13, 2011
Last Updated: August 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Hackensack University Medical Center:
Multiple Myeloma
Transplant

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Fludarabine
Fludarabine phosphate
Melphalan
Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 16, 2014