03047 A Phase II Open-label Trial of VELCADE in VELCADE-naive Patients with Multiple Myeloma Who Have Undergone High-Dose Melphalan Therapy Followed By Autologous Peripheral Blood Stem Cell Transplantation and Failed to Achieve a Complete Response

Principal Investigator: Robert M. Rifkin, MD, FACP

Protocol Number: RMBMT-130

Major Objectives

• To determine if Velcade treatment 60-90 days after high dose melphalan therapy followed by an autologous PBSCT for MM will convert patients with MRD (PR, MR, NC) to complete responders (CR IF-) according to the criteria published by Blade et al or near complete responders (CR IF+) as described by Richardson. A 10% CR (IF-) plus near CR (IF+) rate is expected
• To evaluate the safety of Velcade when administered to patients with MM who have undergone high-dose melphalan therapy followed by autologous PBSCT, and failed to achieve a CR at the time of routine staging (Day 60-90 post PBSCT).

Patient Selection

Inclusion Criteria:

• Has MM and has undergone auto transplant with Melphalan 200mg/m² (total dose) followed by auto PBSCT
• Has had any number of prior therapies and received auto PBSCT and has PR, MR, or NC at least 60 and no more that 90 days post single or double PBSCT for MM without progression of disease.
• Had completed standard mobilization/apheresis regimen with the collection of minimum 2.5 x 10⁶ CD34+ cells.(when transplanted)
• ECOG Performance Score 0 or 1
• 3 consecutive days of ANC ≥ 500 to ensure engraftment
• Baseline labs of :
  • Platelets ≥ 50,000, without platelet transfusion for last 7 days
  • ANC ≥ 1500
  • Hemoglobin ≥ 8.0g/dL
  • LFTS ≤ 2x ULN
  • Creatinine ≤ 2.5mg/dL
• Negative Pregnancy test, and acceptable using birth control method
• If fertile, patient (male or female) has agreed to use acceptable method of birth control for the duration of the study and for at least 2 months thereafter

Exclusion Criteria:

• Received prior VELCADE treatment at any time
• Had an allogeneic transplant
• History of hypersensitivity to compounds containing boron or mannitol.
• History and/or symptoms related to CVA &le 6 months
• Receiving concurrent immunotherapy (Interferon, Interleukin-2, thalidomide) or any treatment for myeloma post-autografting.
• Evidence of CNS involvement
• Uncontrolled intercurrent medical or psychiatric illness or serious infection.
• MI within 6months or Class III or IV heart failure
• History of other malignancy
• HIV +
• Pregnant of nursing woman
• Unable to comply with the requirements of the study.