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A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib

Phase 2
18 Years
69 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

May 2010

Completion Date:

May 2014

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Transplant
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601