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Phase II Trial of Twice Weekly Induction Followed by Once Weekly IV Velcade (Bortezomib) With Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Following at Least 1 Prior Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

Phase II Trial of Twice Weekly Induction Followed by Once Weekly IV Velcade (Bortezomib) With Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Following at Least 1 Prior Therapy


OBJECTIVES:

Primary

- Determine the overall response rate (complete response and partial response) in
patients with relapsed or refractory multiple myeloma treated with induction therapy
and maintenance therapy comprising bortezomib and dexamethasone.

Secondary

- Determine the toxicity of this regimen in these patients

- Determine the tolerability of this regimen in these patients.

- Determine the duration of response in patients treated with this regimen.

- Determine time to progression in patients treated with this regimen.

- Determine overall and progression-free survival of patients treated with this regimen.

OUTLINE: This is an open-label study.

- Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11. Patients
also receive oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats
every 21 days for 4 courses. Patients who achieve complete response (CR) receive an
additional 2 courses of induction therapy and proceed to maintenance therapy.

- Maintenance therapy: Patients receive bortezomib IV on days 1, 8, 15, and 22. Patients
also receive oral dexamethasone on days 1, 2, 8, 9, 15, 16, 22, and 23. Treatment
repeats every 36 days in the absence of disease progression or unacceptable toxicity.
Patients who achieve CR receive an additional 2 courses of maintenance therapy beyond
documentation of CR.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of multiple myeloma

- Refractory or relapsed disease meeting the following criteria:

- Primary refractory disease and first-line relapsing disease

- Progressive disease after last therapy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy > 3 months

- Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ for patients with significant bone marrow
involvement)

- Transfusions allowed

- Hemoglobin ≥ 7.5 g/dL

- Absolute neutrophil count ≥ 750/mm³

- Serum calcium < 14 mg/dL

- AST and ALT < 2.5 times upper limit of normal

- Creatinine clearance ≥ 30 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No peripheral neuropathy ≥ grade 2 within the past 14 days

- No hypersensitivity to boron or mannitol

- No cardiovascular complications, including any of the following:

- Myocardial infarction within the past 6 months

- New York Heart Association class III-IV heart failure

- Uncontrolled angina

- Ventricular arrhythmias

- Electrocardiographic evidence of acute ischemia or active conduction system
abnormalities

- Cardiac amyloidosis

- No other cancer or treatment for cancer other than basal cell cancer of the skin
within the past 5 years

- No poorly controlled chronic diseases (e.g., diabetes mellitus or hypertension)

- No HIV positivity

- No hepatitis B surface antigen or active hepatitis C infection

- No active systemic infection requiring therapy

- No serious medical or psychiatric illness that would interfere with study
participation

PRIOR CONCURRENT THERAPY:

- No plasmapheresis within the past 4 weeks

- No major surgery within the past 4 weeks

- No prior bortezomib

- No chemotherapy (e.g., clarithromycin) within the past 4 weeks

- No radiotherapy within the past 3 weeks

- No corticosteroids (> 10 mg/day of prednisone or equivalent) within the past 3 weeks

- No other immunotherapy within the past 8 weeks

- No other investigational drugs within the past 14 days

- No concurrent participation in other clinical research studies

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Safety Issue:

No

Principal Investigator

Gordan Srkalovic, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Sparrow Regional Cancer Center

Authority:

Unspecified

Study ID:

CDR0000509044

NCT ID:

NCT00389701

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Sparrow Regional Cancer CenterLansing, Michigan  48912-1811