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Phase II Study to Evaluate Efficacy and Safety of Single Weekly Administration of Bortezomib in Newly Diagnosed Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Phase II Study to Evaluate Efficacy and Safety of Single Weekly Administration of Bortezomib in Newly Diagnosed Multiple Myeloma

This study is a multi-site study which will enroll up to 50 patients with multiple myeloma
who have not had prior treatment.

Prior to starting treatment individuals will be evaluated to determine if they are eligible
to participate in the study. There are certain prestudy test that are required: physical
exam, blood tests, ECG, chest x-ray, skeletal survey, bone marrow aspirate and biopsy to
confirm the diagnosis of multiple myeloma and to determine baseline health status.

Before beginning each treatment cycle and at the end of the study, patients will have
protein studies (including blood and urine) to see if they are responding to the treatment.
Before each weekly treatment cycle patients will also have blood tests for red and white
blood cells and platelets, and blood chemistry tests for electrolytes, kidney and liver
function, calcium and blood sugar.

Patients may receive up to 6 cycles of treatment. At the end of the study, individuals who
have responded to treatment will be seen every two months to check for disease progression.

Inclusion Criteria:

1. Diagnosis of multiple myeloma based on standard criteria.

2. Measurable disease, defined as a monoclonal immunoglobulin spike on serum
electrophoresis of > 1Gm/dL and/or urine monoclonal immunoglobulin spike of >
200mg/24 hours.

3. Non-secretors must have measurable protein by Freelite or measurable disease such as
plasmacytoma to be eligible.

4. Patient must not have been previously treated with chemotherapy. Prior treatment of
hypercalcemia with corticosteroids, or bisphosphonates does not disqualify the

5. Patient must be ineligible for autologous stem cell transplant due to one or more of
the following reasons:

- Age>65

- Impaired renal function (creatinine≥2.0 mg/dL)

- Impaired pulmonary function (DLCO≤50%)

- Poor performance status (KPS≤80)

- Other prohibitive comorbid disorder

- 5b. Patients≥60 who decline autologous stem cell transplant are eligible
for this study.

- 5c. Patients who are eligible but wish to postpone autologous stem cell
transplant are eligible for this study.

6. Karnofsky performance status>50

7. Patients treated with local radiotherapy with or without a brief exposure to steroids
are eligible. Patients who require concurrent radiotherapy should have entry to the
protocol deferred until the radiotherapy is completed, followed by a four week wash
out period Spot RT to ≤3 vertebrae acceptable prior to entry.

8. Meets the following pretreatment laboratory criteria at Baseline (Within 14 days
prior to study drug administration):

1. Platelet count>50x10^9/L or, if the bone marrow is extensively

2. Hemoglobin>8.0G/dL

3. Absolute neutrophil count >1.0x10^9/L or, if the bone marrow is extensively
infiltrated, >0.5x10^9/L

9. Meets the following pretreatment laboratory criteria for liver function tests at the
screening visit conducted within 14 days of registration

1. AST (SGOT): <3 times the upper limit of institutional laboratory normal

2. ALT (SGPT): <3 times the upper limit of institutional laboratory normal

3. Total bilirubin: <2 times the upper limit of institutional laboratory normal,
unless clearly related to the disease

10. Women with child-bearing potential should be practicing an adequate form of
contraception, as judged by the investigator (i.e. birth control pills, double
barrier method, abstinence, etc.) or be surgically sterile or 12 months
post-menopausal. Male subject agrees to use an acceptable method for contraception
for the duration of the study.

11. Age 18 years or older

12. Has given voluntary written informed consent.

Exclusion Criteria:

1. POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein (M-protein) and skin changes)

2. Plasma cell leukemia

3. Impaired kidney function requiring dialysis, patients on hemodialysis are excluded

4. Receiving steroids >the equivalent of 10mg prednisone daily for other medical
conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis

5. Infection not controlled by antibiotics

6. HIV infection. Patients should provide consent for HIV testing according to the
institution's standard practice

7. Known active hepatitis B or C

8. Myocardial infarction within 6 months prior to enrollment or has New York Heart
Association (NYHA) Class III or IV heart failure (Appendix D), uncontrolled angina,
severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of
acute ischemia or active conduction system abnormalities

9. Second malignancy requiring concurrent treatment

10. Other serious medical or psychiatric illness that could potentially interfere with
the completion of treatment according to this protocol

11. Positive pregnancy test in women of childbearing potential

12. Patient has hypersensitivity to boron or mannitol.

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

14. Patient has received other investigational drugs with 14 days before enrollment

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the objective response rate (CR + PR) to weekly bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.

Outcome Time Frame:

Approximately 3 years

Safety Issue:


Principal Investigator

Nikhil C. Munshi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston VA Research Institute, Inc.


United States: VA Boston Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Bortezomib
  • Newly diagnosed
  • Newly diagnosed Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Atlanta Va Medical Center Decatur, Georgia  30033
San Francisco VA Medical Center San Francisco, California  94110
Kansas City VA Medical Center Kansas City, Missouri  64128
Michael E. DeBakey VA Medical Center Houston, Texas  77030
VA Boston Healthcare System Boston, Massachusetts  02130
Little Rock VA Medical Center Little Rock, Arkansas  72205
West Los Angeles VA Medical Center Los Angeles, California  90073
Eastern Colorado Health Care System Denver, Colorado  80220
West Haven VA Medical Center West Haven, Connecticut  06516
Tampa VA Medical Center Tampa, Florida  33612
Pittsburgh VA Medical Center Pittsburgh, Pennsylvania  15240