Status:
COMPLETED
Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Neurotoxicity
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE2
Brief Summary
RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes ...
Detailed Description
OBJECTIVES: Primary * To assess the feasibility and toxicities of maintenance therapy with sequential bortezomib, thalidomide, and dexamethasone after high-dose melphalan and autologous peripheral b...
Eligibility Criteria
Inclusion
- Multiple Myeloma patients with symptomatic disease, stage II or III at diagnosis or progressive stage I requiring chemotherapy and/or radiation therapy (by Salmon-Durie classification), who are not eligible for tandem transplant study using TMI; because of previous radiation or eligibility criteria; documentation of disease staging by both Salmon-Durie classification and International Staging System (ISS) is required
- Patients with non-secretory myeloma should have measurable serum free-light chain protein by the Free-lite test or measurable disease such as a soft tissue myeloma
- A minimum of 4 x 10\^6 of CD 34 Positive cell/kg has been harvested
- A Karnofsky performance status (KPS) of \>= 70% is required unless the KPS is impaired due to bone disease
- No contraindication to the collection of a minimum of 4 x 10\^6 CD34+ cells/kg by apheresis
- All patients must have signed a voluntary, informed consent in accordance with institutional and federal guidelines
- Bilirubin =\< 1.5 mg/dl
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) \< 2.5 x upper limits of normal
- Creatinine clearance of \>= 40cc/min
- Absolute neutrophil count of \> 1000/ul
- Platelet count of \> 100,000/ul
- Cardiac ejection fraction \>= 45% by multigated acquisition (MUGA) scan and/or by echocardiogram
- Diffusing capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted lower limit
- Human immunodeficiency virus (HIV) antibody tests negative
- No other medical, or psychosocial problems which in the opinion of the primary physician or principal investigator would place the patient at unacceptably high risk from this treatment regimen
Exclusion
- Presence of peripheral neuropathy \>= grade II
- Patients with evidence of disease progression (with \>= 25% increase in M protein) on bortezomib and or thalidomide therapy prior to transplant
- Pregnant or nursing women, as well as women of child bearing age, who are unwilling to use a dual method of contraception and men who are unwilling to use condom
- Patients with history of hypersensitivity to bortezomib, boron or mannitol
Key Trial Info
Start Date :
January 16 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00792142
Start Date
January 16 2008
End Date
April 21 2014
Last Update
August 19 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope Medical Center
Duarte, California, United States, 91010-3000