Bortezomib, Ascorbic Acid, and Melphalan in Treating Patients With Newly Diagnosed Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00317811|
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : November 6, 2013
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help melphalan work better by making cancer cells more sensitive to the drug. Giving bortezomib together with ascorbic acid and melphalan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with ascorbic acid and melphalan works in treating patients with newly diagnosed multiple myeloma.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Dietary Supplement: ascorbic acid Drug: bortezomib Drug: melphalan||Phase 2|
- Determine the overall response rate (combined complete response [CR], near CR, partial response [PR], and minimal response [MR]) and time to progression of disease in patients with newly diagnosed multiple myeloma treated with bortezomib, ascorbic acid, and melphalan.
- Assess the safety and tolerability of this regimen in these patients.
- Assess the time to response in these patients.
- Determine progression-free and overall survival of these patients.
- Assess time to disease progression among subjects who continue to maintenance treatment with bortezomib.
OUTLINE: This is an open-label study.
- Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral melphalan and oral ascorbic acid on days 1-4. Treatment repeats every 28 days to maximum response [MR] or for at least 8 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive an additional 2 courses of induction therapy beyond MR and proceed to maintenance therapy. Patients with stable disease or without a maximum reduction in their paraprotein after 8 courses of induction therapy are eligible to receive maintenance therapy.
- Maintenance therapy: Patients receive bortezomib IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Bortezomib + Ascorbic Acid + Melphalan (BAM) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||February 2009|
- Overall response rate (complete response [CR], near CR, partial response, and minimal response)
- Safety and tolerability as assessed by NCI CTCAE v3.0
- Proportion of patients responding
- Time to disease progressionin patients receiving maintenance treatment
- Time to response
- Progression-free survival
- Overall survival as assessed by the Kaplan-Meier method
- Time to disease progression
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317811
|United States, California|
|Hematology-Oncology Medical Group of Fresno, Incorporated|
|Fresno, California, United States, 93720|
|Hematology Oncology Medical Group of Orange County, Incorporated|
|Orange, California, United States, 92868|
|West Hollywood, California, United States, 90069|
|United States, Florida|
|Florida Cancer Specialists - Bonita Springs|
|Bonita Springs, Florida, United States, 34135|
|Florida Oncology Associates|
|Orange Park, Florida, United States, 32073|
|United States, Georgia|
|Atlanta Cancer Care - Roswell|
|Roswell, Georgia, United States, 30076|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, New York|
|SUNY Downstate Medical Center|
|Brooklyn, New York, United States, 11203|
|Principal Investigator:||James R. Berenson, MD||Oncotherapeutics|