Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00287872

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: bortezomib Drug: thalidomide	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Thalidomide Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	VELCADE (Bortezomib) and Thalidomide in Newly Diagnosed Patients With Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Antitumor efficacy [ Designated as safety issue: No ]
Incidence and severity of peripheral motor/sensory neuropathy [ Designated as safety issue: No ]
Mobilization and collection of stem cells [ Designated as safety issue: No ]
Time to response [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]

Estimated Enrollment:	35
Study Start Date:	September 2004

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287872

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Ivan Borrello, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000450772, JHOC-J0456, JHOC-04063003, MILLENNIUM-JHOC-J0456
Study First Received:	February 6, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00287872 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:

Immunoproliferative Disorders
Immunologic Factors
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Angiogenesis Inhibitors
Immunosuppressive Agents
Protease Inhibitors
Multiple Myeloma
Anti-Bacterial Agents
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Thalidomide
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Paraproteinemias
Hemostatic Disorders
Anti-Bacterial Agents
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents

Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Hematologic Diseases
Growth Substances
Bortezomib
Vascular Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Multiple Myeloma
Neoplasms
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 07, 2009