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

Hackensack Meridian Health

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Fludarabine monophosphate, melphalan, Bortezomib

Study type

Interventional

Funder types

Other

Identifiers

NCT01453101

PRO1261

Details and patient eligibility

About

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.

Full 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%.

Enrollment

54 patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

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