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

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: NCT01453101
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : May 25, 2022
Last Update Posted : May 25, 2022
Information provided by (Responsible Party):
Hackensack Meridian Health

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: Fludarabine monophosphate, melphalan, Bortezomib Phase 2

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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : June 9, 2010
Actual Primary Completion Date : June 11, 2020
Actual Study Completion Date : June 11, 2020

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Subjects will be followed for progression-free survival for at least 36 months ]
    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.

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 3 years ]
    Overall survival (OS): Defined as time from the first dose of administration to death from any cause

  2. Overall Response Rate [ Time Frame: Up to 3 years ]

    Overall response rate: Defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria.

    International Myeloma Working Group Response Criteria for Multiple Myeloma:

    CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h SD: Not meeting criteria for CR, VGPR, PR, or progressive disease

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01453101

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United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack Meridian Health
  Study Documents (Full-Text)

Documents provided by Hackensack Meridian Health:
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Responsible Party: Hackensack Meridian Health Identifier: NCT01453101    
Other Study ID Numbers: PRO1261
First Posted: October 17, 2011    Key Record Dates
Results First Posted: May 25, 2022
Last Update Posted: May 25, 2022
Last Verified: April 2022
Keywords provided by Hackensack Meridian Health:
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists