2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
- Conditions
- Plasma Cell NeoplasmMultiple Myeloma
- Interventions
- Biological: filgrastimProcedure: autologous stem cell transplantationProcedure: stem cell infusion
- Registration Number
- NCT00075608
- Lead Sponsor
- Boston Medical Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly.
PURPOSE: This phase II trial is studying how well autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic (AL) amyloidosis.
- Detailed Description
OBJECTIVES:
* Determine the feasibility and tolerability of second autologous stem cell transplantation in patients with persistent or recurrent AL amyloidosis.
* Determine the response rate and durability of response in patients treated with this regimen.
* Determine immune reconstitution in patients treated with this regimen.
OUTLINE:
* Mobilization: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection.
* Preparative regimen: Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2.
* Autologous stem cell transplantation: Autologous stem cells are reinfused on day 0.
Patients are followed at 6 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19 patients will be accrued for this study within 5-6 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
Not provided
- No myelodysplastic syndromes
- No abnormal bone marrow cytogenetics
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Acceptable toxicity from first transplantation, confirmed by the transplant team
- HIV negative
- No other concurrent malignancy except treated skin cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 2nd Stem Cell Transplant filgrastim Mobilization with filgrastim autologous stem cell transplantation with melphalan conditioning stem cell infusion 2nd Stem Cell Transplant autologous stem cell transplantation Mobilization with filgrastim autologous stem cell transplantation with melphalan conditioning stem cell infusion 2nd Stem Cell Transplant stem cell infusion Mobilization with filgrastim autologous stem cell transplantation with melphalan conditioning stem cell infusion 2nd Stem Cell Transplant melphalan Mobilization with filgrastim autologous stem cell transplantation with melphalan conditioning stem cell infusion
- Primary Outcome Measures
Name Time Method Feasibility and Tolerability 3 months after treatment and annually Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events
Response and Durability of Response 3 months after treatment and annually Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death
Evaluate Immune Reconstitution 3 months after treatment and annually Evaluate immune reconstitution based on time to engraftment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States