Clinical trial NCT00287872: Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma
Official title: VELCADE (Bortezomib) and Thalidomide in Newly Diagnosed Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: stage II multiple myeloma
stage III multiple myeloma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Clinical Response to Treatment
timeFrame: 1-6 months
Secondary outcomes:
measure: Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher)
timeFrame: 1-6 months
measure: Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation
timeFrame: 1-6 months
measure: The Time to Response
timeFrame: 1-6 months
measure: Quality of Life
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Ivan Borrello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghosh N, Ye X, Ferguson A, Huff CA, Borrello I. Bortezomib and thalidomide, a steroid free regimen in newly diagnosed patients with multiple myeloma. Br J Haematol. 2011 Mar;152(5):593-9. doi: 10.1111/j.1365-2141.2010.08534.x. Epub 2011 Jan 17.