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Combination High Dose Melphalan and Autologous PBSC Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study

Phase 1/Phase 2
18 Years
Not Enrolling
Cancer, Multiple Myeloma

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Trial Information

Combination High Dose Melphalan and Autologous PBSC Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study

Inclusion Criteria:

- Patients with multiple myeloma who are eligible for an autologous peripheral blood
progenitor transplant

- Male and female subjects between the age of 18 and 70 years.

- Patient has given informed consent prior to any study related procedures with the
knowledge that consent can be withdrawn at anytime without prejudice to future
medical care

- Patient is, in the investigator's opinion, willing and able to comply with the
protocol requirements

- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study.

- Male subjects agrees to use an acceptable method for contraception for the duration
of the study.

- Biopsy proven diagnosis of multiple myeloma from bone marrow aspirate and biopsy
prior to study initiation

- Patient has achieved less than 90% disease reduction from previous treatment prior to
transplant (as measured by serum or urine protein electrophoresis) and has more than
5% plasma cells in the bone marrow, or patient has progressed and has more than 5%
plasma cells in the bone marrow.

- Karnofsky Performance Status score of ≥ 60%

- Patient has met the following laboratory requirements prior to Day -4

- Platelet count ≥ 50, 000/mm3

- Absolute Neutrophil Count ≥ 500/mm3

- Hemoglobin ≥ 10 g/dL (transfusion allowed to meet this criterion)

- Calculated creatinine clearance ≥ 30mL/min

- Toxic effects of previous therapy or surgery resolved to Grade 2 or better

Exclusion Criteria:

- Unsupportable anemia with < 10b/dL

- Patient has a calculated or measured creatinine clearance of < 30mL/min within 14
days before enrollment

- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment

- Patient has hypersensitivity to bortezomib, boron or mannitol

- Patient has had an allergic reaction to melphalan or chlorambucil

- Female subject is pregnant or breast-feeding. Confirmation that the subject is not
pregnant must be established by a negative serum β-human chorionic gonadotropin
(β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not
required for post-menopausal or surgically sterilized women.

- 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

- Cardiac or pulmonary dysfunction such that patients do not meet institutional
pre-transplant evaluation criteria

- Known central nervous system involvement or suspicion of involvement with Myeloma

- Other active malignancies (with the exception of basal and squamous cell skin cancer)
within 5 years of study entry. Patients with treated prostate or cervical cancer in
situ who are 2 or more years from therapy and remain free of disease may be entered
into the study at the investigator's discretion.

- Known to be HIV positive, HIV-1 positive

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Engraftment

Outcome Description:

Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.

Outcome Time Frame:

Day 30 after transplant

Safety Issue:


Principal Investigator

Sagar Lonial, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

September 2011

Related Keywords:

  • Cancer
  • Multiple Myeloma
  • Cancer
  • Multiple Myeloma
  • Peripheral Blood Stem Cell Transplant
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Emory University Winship Cancer InstituteAtlanta, Georgia  30322