Bortezomib and Dexamethasone in Treating Patients With Multiple Myeloma That Has Relapsed or Has Not Responded to Treatment

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00389701
• Other study ID #: CDR0000509044
• Secondary ID: SPARROW-I071-341
• Status: Recruiting
• Phase: Phase 2
• First received: October 18, 2006
• Last updated: January 9, 2014
• Start date: March 2006

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with dexamethasone may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with dexamethasone works in treating patients with multiple myeloma that has relapsed or has not responded to treatment.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Drug:
• bortezomib

• dexamethasone

Locations

Country	Name	City	State
United States	Sparrow Regional Cancer Center	Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Sparrow Regional Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate			No
Secondary	Toxicity			Yes
Secondary	Tolerability			Yes
Secondary	Duration of response after completion of treatment			No
Secondary	Time to progression			No
Secondary	Overall and progression-free survival			No