Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma

Johns Hopkins Medicine

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: bortezomib

Drug: thalidomide

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00287872

JHOC-04063003

P30CA006973 (U.S. NIH Grant/Contract)

MILLENNIUM-JHOC-J0456

JHOC-J0456

J0456 CDR0000450772

Details and patient eligibility

About

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide works in treating patients with newly diagnosed stage II or stage III multiple myeloma.

Full description

OBJECTIVES:

Determine the antitumor efficacy of bortezomib and thalidomide in patients with newly diagnosed stage II or III multiple myeloma.
Determine the incidence and severity of peripheral motor/sensory neuropathy in patients treated with this regimen.
Assess the ability to mobilize and collect stem cells in patients who undergo future autologous peripheral stem cell transplantation.
Determine the time to response in patients treated with this regimen.
Assess the quality of life of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses. Patients who plan to undergo transplantation AND achieve ≥ 50% reduction in the tumor burden proceed to transplantation off study. Patients who do not undergo transplantation receive 2 additional courses of therapy beyond best response for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve at least a partial response after completion of treatment may receive maintenance therapy comprising bortezomib IV every 2 months and oral thalidomide* once daily OR twice every 2 months (i.e., the day before and the day of bortezomib administration) in the absence of disease progression or unacceptable toxicity.

NOTE: *For patients who had previously discontinued thalidomide, maintenance therapy may consist of bortezomib only.

Quality of life is assessed at baseline, at the beginning of each study course, and after completion of study treatment.

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

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Newly diagnosed Salmon-Durie stage II or III multiple myeloma
- Untreated disease OR patient underwent prior therapy for this cancer that lasted no more than 2 weeks
Measurable paraprotein in serum or urine (serum free-lite assay measurement allowed)
No evidence of cord compression requiring concurrent steroids

PATIENT CHARACTERISTICS:

Creatinine clearance ≥ 30 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 methods of contraception, including ≥ 1 highly effective method, 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
No known HIV positivity
No peripheral neuropathy ≥ grade 2
No hypersensitivity to bortezomib, boron, or mannitol

PRIOR CONCURRENT THERAPY:

No prior bortezomib
More than 28 days since prior regimens with a duration of > 1 week but ≤ 2 weeks
No steroids within 14 days prior to study entry
No concurrent corticosteroids except for the treatment of a nonmalignant condition
- May not exceed the equivalent dose of prednisone 10 mg/day
No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery
No other concurrent investigational agents