Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477971
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2007-05-23
Brief Title:
Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase III Trial of Stem Cell Transplantation Compared to Parenteral Melphalan and Oral Dexamethasone in the Treatment of Primary Systemic Amyloidosis AL
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as melphalan and dexamethasone work in different ways to stop the growth of plasma cells either by killing the cells or by stopping them from dividing Having an autologous 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 It is not yet known whether combination chemotherapy is more effective than chemotherapy followed by an autologous stem cell transplant in treating primary systemic amyloidosis
PURPOSE This randomized phase III trial is studying the side effects and how well giving low-dose melphalan together with dexamethasone works compared with high-dose melphalan followed by an autologous stem cell transplant in treating patients with primary systemic amyloidosis
PURPOSE This randomized phase III trial is studying the side effects and how well giving low-dose melphalan together with dexamethasone works compared with high-dose melphalan followed by an autologous stem cell transplant in treating patients with primary systemic amyloidosis
Detailed Description:
OBJECTIVES
Primary
Compare hematologic response rate in patients with primary systemic amyloidosis treated with conventional chemotherapy comprising low-dose melphalan and dexamethasone vs high-dose melphalan followed by autologous stem cell transplantation
Compare the toxicity of these regimens in these patients
Secondary
Compare the overall and progression-free survival of patients treated with these regimens
Compare the regression of organ involvement in patients treated with these regimens
Compare the duration of response in patients treated with these regimens
Correlate clonal burden and time to in vitro amyloid formation with clinical outcomes in patients treated with these regimens
Compare quality of life of patients treated with these regimens
Compare the information-seeking behavior in patients treated with these regimens
OUTLINE This is a comprehensive cohort study comprising a randomized option and a nonrandomized option Patients consenting to randomization are stratified by risk group high vs low and ECOG performance status 0-1 vs 2 They are then randomized to 1 of 2 treatment arms Patients not consenting to randomization choose their treatment arm
Arm I Patients receive low-dose melphalan IV over 15-30 minutes on day 1 or orally once daily on days 1-7 and oral dexamethasone on days 1-4 and 22-25 Treatment repeats every 6 weeks for 10 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive filgrastim G-CSF on days -7 to -3 and undergo autologous hematopoietic stem cell HSC collection Patients receive high-dose melphalan IV over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0
Blood and bone marrow samples are collected at baseline Samples are examined by PCR cDNA and nucleotide sequence analysis to determine VH and VL gene families and carrier status Urine is collected at baseline and analyzed for light-chain protein levels by exclusion chromatography
Quality of life is assessed at baseline at months 3 9 and 12 at completion of study treatment and then every 6 months for up to 5 years
After completion of study treatment patients are followed every 6 months for up to 10 years
Primary
Compare hematologic response rate in patients with primary systemic amyloidosis treated with conventional chemotherapy comprising low-dose melphalan and dexamethasone vs high-dose melphalan followed by autologous stem cell transplantation
Compare the toxicity of these regimens in these patients
Secondary
Compare the overall and progression-free survival of patients treated with these regimens
Compare the regression of organ involvement in patients treated with these regimens
Compare the duration of response in patients treated with these regimens
Correlate clonal burden and time to in vitro amyloid formation with clinical outcomes in patients treated with these regimens
Compare quality of life of patients treated with these regimens
Compare the information-seeking behavior in patients treated with these regimens
OUTLINE This is a comprehensive cohort study comprising a randomized option and a nonrandomized option Patients consenting to randomization are stratified by risk group high vs low and ECOG performance status 0-1 vs 2 They are then randomized to 1 of 2 treatment arms Patients not consenting to randomization choose their treatment arm
Arm I Patients receive low-dose melphalan IV over 15-30 minutes on day 1 or orally once daily on days 1-7 and oral dexamethasone on days 1-4 and 22-25 Treatment repeats every 6 weeks for 10 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive filgrastim G-CSF on days -7 to -3 and undergo autologous hematopoietic stem cell HSC collection Patients receive high-dose melphalan IV over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0
Blood and bone marrow samples are collected at baseline Samples are examined by PCR cDNA and nucleotide sequence analysis to determine VH and VL gene families and carrier status Urine is collected at baseline and analyzed for light-chain protein levels by exclusion chromatography
Quality of life is assessed at baseline at months 3 9 and 12 at completion of study treatment and then every 6 months for up to 5 years
After completion of study treatment patients are followed every 6 months for up to 10 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-01329 | REGISTRY | NCI-CTRP | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| MC0482 | OTHER | None | None |
| 1691-05 | OTHER | None | None |