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

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

bortezomib

dexamethasone

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sparrow Regional Cancer CenterRecruiting

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Toxicity

Tolerability

Duration of response after completion of treatment

Time to progression

Overall and progression-free survival

Full Information

NCT ID

NCT00389701

First Posted

October 18, 2006

Last Updated

January 9, 2014

Sponsor

Sparrow Regional Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00389701

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

March 2006 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sparrow Regional Cancer Center

4. Oversight

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

bortezomib

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Primary Outcome Measure Information:

Title

Overall response rate

Secondary Outcome Measure Information:

Title

Toxicity

Title

Tolerability

Title

Duration of response after completion of treatment

Title

Time to progression

Title

Overall and progression-free survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gordan Srkalovic, MD, PhD

Organizational Affiliation

Sparrow Regional Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Sparrow Regional Cancer Center

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48909-7980

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gordan Srkalovic, MD, PhD

Phone

517-364-2467

gordan.srkalovic@sparrow.org

12. IPD Sharing Statement

Learn more about this trial

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

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