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

NCT00287872 | Completed Phase 2 Results DMC

• 5 other identifiers: J0456 CDR0000450772P30CA006973JHOC-J0456JHOC-04063003MILLENNIUM-JHOC-J0456
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Clinical Response to Treatment

  Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria: Stringent Complete Response (SCR), CR and normal free light chain ratio and no clonal cells in bone marrow; Complete Response (CR), Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; Very Good Partial Response (VGPR), Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; Partial Response (PR), ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. Objective response is defined as a best overall response of SCR, CR, VGPR, or PR.

  1-6 months

Secondary Outcomes (4)

• Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher)

  1-6 months

• Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation

  1-6 months

• The Time to Response

  1-6 months

• Quality of Life

  0-6 months

Study Arms (1)

Bortezomib and Thalidomide

EXPERIMENTAL

The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.

Drug: bortezomib; Drug: thalidomide

Interventions

bortezomib DRUG

Also known as: VELCADE

Bortezomib and Thalidomide

thalidomide DRUG

Bortezomib and Thalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

• 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.

  PMID: 21241279 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Ivan Borrello
• Organization: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

iborrell@jhmi.edu

(410) 955-4967

Study Officials

• Ivan Borrello, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: September 1, 2004
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 1, 2018
• Results First Posted: July 23, 2014

Record last verified: 2014-06

Locations

US (1)