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A Phase I/II Study of Escalating Doses of Bortezomib in Conjunction With High Dose Melphalan as a Conditioning Regimen for Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma


Phase 1/Phase 2
18 Years
76 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase I/II Study of Escalating Doses of Bortezomib in Conjunction With High Dose Melphalan as a Conditioning Regimen for Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma


Multiple myeloma is the second most common hematological malignancy that has affected
approximately 40,000 Americans.Conventional chemotherapy has achieved limited control of
this disease but studies have reported improved response rates for patients who are treated
with dose-intense therapy and autologous hematopoietic stem cell transplantation. This Phase
I/II study will investigate the potential of combination therapy of dose-intense melphalan
with escalating doses of bortezomib.


Inclusion Criteria:



1. A confirmed diagnosis of multiple myeloma

2. Show progression of disease after a previous cycle of dose-intense melphalan, or less
than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of
dose-intense melphalan

- May have received intervening therapies for disease progression after
dose-intense melphalan and enrollment in this protocol

3. Age:18yrs-76yrs at time of melphalan administration

4. Gender: There is no gender restriction

5. Availability of >2x10^6 autologous peripheral blood CD34+ cells/kg or a syngeneic
donor meeting eligibility criteria for syngeneic donation

- Syngeneic transplantation is preferred

- For patients enrolled in the phase I part of this study, >1x10^6 autologous or
syngeneic peripheral blood CD34+ cells/kg remaining in storage as "backup" in
case of engraftment failure

6. Recovery from complications of salvage therapy, if administered -

Exclusion Criteria:

1. Diagnosis other than multiple myeloma

2. Chemotherapy or radiotherapy within 28 days of initiating treatment in this study

3. Prior dose-intense therapy within 56 days of initiating treatment in this study

4. Uncontrolled bacterial,viral,fungal or parasitic infections

5. Uncontrolled CNS metastases

6. Known amyloid deposition in heart

7. 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 <20ml/min

- Sensory peripheral neuropathy grade 4

8. Karnofsky score<70% unless a result of bone disease directly caused by myeloma

9. Life expectancy limited by another co-morbid illness

10. History of another malignancy in remission <2yrs (other than basal cell carcinoma)

11. Pregnant (women)or unwilling to use acceptable birth control methods (men or women)
for twelve months after treatment

12. Documented hypersensitivity to melphalan or bortezomib or any components of the
formulation

13. Patients unable or unwilling to provide consent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose The maximum tolerated dose of bortezomib (MTD) will be defined as the dose level prior to that resulting in two out of six patients experiencing a DLT

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Scott D Rowley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Director-Blood and Marrow Transplantation Program

Authority:

United States: Institutional Review Board

Study ID:

06.05.109B

NCT ID:

NCT00784823

Start Date:

January 2007

Completion Date:

December 2009

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Hackensack University Medical CenterHackensack, New Jersey  07601