Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma

NCT00075881 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2014-00652CDR0000349450E2A02U10CA021115
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well bortezomib works in treating patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Conditions

Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Response Rate on Induction

  Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.

  participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days

Secondary Outcomes (3)

• Response Rate on Maintenance

  participants were evaluated prior to each cycle, up to 45 cycles with a median number of 9 cycles. 1 cycle=21 days

• Response Rate on Reinduction

  participants were evaluated prior to each cycle, up to 23 cycles with a median number of 3 cycles. 1 cycle=21 days

• 1-year Progression Free Survival Probability

  Every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-6 years from study entry, no specific requirment if patient is more than 6 years from study entry

Study Arms (1)

Treatment (bortezomib)

EXPERIMENTAL

INDUCTION TREATMENT: Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE TREATMENT: Patients who complete induction treatment without progressive disease receive bortezomib IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. REINDUCTION TREATMENT: Patients who progress while on maintenance treatment receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Drug: bortezomib; Other: laboratory biomarker analysis

Interventions

bortezomib DRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE

Treatment (bortezomib)

laboratory biomarker analysis OTHER

Optional correlative studies

Treatment (bortezomib)

Eligibility Criteria

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

You may qualify if:

• Patients must not have received prior myeloma specific therapy (chemotherapy, radiotherapy, or biologic therapy) other than bisphosphonate therapy
• Patients may have received radiation of plasmacytoma (for example, solitary plasmacytoma); the last such treatment must have occurred \>= 4 weeks prior to registration
• Patients must be recently diagnosed with symptomatic multiple myeloma confirmed by meeting one or more of the following criteria (obtained =\< 30 days prior to registration):
• NOTE: serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP) and marrow biopsy all must be done at baseline in order to evaluate response
• Monoclonal protein in the serum \>= 1 g/dl (measurable disease), or
• Monoclonal light chain in the urine protein electrophoresis \>= 200 mg/24 hours (measurable disease), or
• Bone marrow plasmacytosis \>= 30% without either of the values in above (evaluable disease)
• Patients must meet one or more of the following (all tests must be been drawn =\< 30 days prior to registration but all results are not required to be available at time of registration as long as at least one of the following criteria has been met; if patient is otherwise eligible, plasma cell labeling index \[PCLI\] is not required, but is requested):
• Beta-2 microglobulin \>= 5.5 mcg/mL, or
• PCLI \>= 1, or
• Deletion 13 by cytogenetics
• Platelet count \>= 20,000/mm\^3, with or without transfusion support
• Hemoglobin \>= 7.0 g/dL, with or without transfusion support
• Absolute neutrophil count (ANC) \>= 500/mm\^3 without growth factor support
• Direct bilirubin within =\< 1.5 x upper normal limits (UNL)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

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

Results Point of Contact

• Title: Study Statistician
• Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office

617-632-3012

Study Officials

• Angela Dispenzieri

  Eastern Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 13, 2004
• Study Start: January 1, 2004
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 2, 2014
• Results First Posted: September 28, 2012

Record last verified: 2014-03

Locations

US (1)