Multiple Myeloma Clinical Trial
Official title:
High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma
Verified date | May 2013 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this phase II study is to assess the toxicity and efficacy of sequentially administered high dose chemotherapy followed by autologous stem cell rescue in the treatment of multiple myeloma. Prior studies have shown that dose-intensified melphalan can produce higher response rates and complete remission in some patients. Over the past several years, multiple phase II studies utilizing high dose chemotherapy or high dose chemo-radiotherapy with autologous marrow or peripheral blood stem cell rescue have demonstrated improved response rates and survival rates compared to historical controls. Recently a prospective randomized trial has demonstrated improved response rates, response duration and overall survival utilizing high dose therapy with autologous bone marrow support compared to standard chemotherapy. The primary cause of failure is relapse and it is unclear how many, if any, patients are cured by this approach. Based on observations of efficacy in Hodgkin's Disease, Non-Hodgkin's Lymphoma, and breast cancer, an approach utilizing sequential high dose chemotherapy in multiple myeloma was developed. This protocol tests the sequential regimen in multiple myeloma patients who have responded to a standard dose chemotherapy regimen prior to enrollment.
Status | Completed |
Enrollment | 91 |
Est. completion date | February 2008 |
Est. primary completion date | January 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients must receive multi-agent based chemotherapy, preferably VAD, as cytoreduction prior to transplantation. The time from the last chemotherapy administration must be greater than 21 days. Patients with recurrent myeloma must have sensitive disease as demonstrated by a decrease in serum or urine paraprotein levels of >50% or a decrease in bone marrow plasmacytosis to less than 20%. Patients with newly diagnosed myeloma may have stable (but not progressive) disease following VAD. - Patients must have their pathology reviewed and the diagnosis of multiple myeloma confirmed at the transplant center. Patients with smoldering multiple myeloma or benign monoclonal gammopathy of unknown significance will be excluded from this study. - Performance status: -CALGB 0.1 or Karnofsky greater than 70% - Patients must have serum creatinine < 2 x upper limit of normal, bilirubin < 2 x upper limit of normal, transaminases < 2 x upper limit of normal, MUGA resting EF > 50% or more than a 5% increase with exercise if <50%, DLCO > 60% Exclusion Criteria: - Patients who have undergone bone marrow transplantation previously will not be eligible. - Patients with HIV, HBsAG positive - Pregnant or lactating women - Patients with other medical or psychiatric disorders which would seriously compromise tolerance to this protocol. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Duke University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the progression free survival at one year in multiple myeloma patients who receive sequentially administered high dose cyclophosphamide and VP-16 followed by high-dose BCNU (Carmustine) plus Melphalan | 4 years | Yes | |
Secondary | To evaluate the response rates of multiple myeloma patients to this sequentially administered high dose chemotherapy. | 4 years | No | |
Secondary | To evaluate the safety and toxicity of this sequential high dose chemotherapy program in multiple myeloma patients. | 4 years | Yes |
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