Study Stopped
poor accrual
2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
Phase II Trial of Second Autologous Transplantation in AL Amyloidosis
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 multiple-myeloma
Started Aug 2001
Longer than P75 for phase_2 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
January 9, 2004
CompletedFirst Posted
Study publicly available on registry
January 12, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
January 27, 2017
CompletedJanuary 27, 2017
December 1, 2016
10.2 years
January 9, 2004
August 20, 2014
December 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility and Tolerability
Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events
3 months after treatment and annually
Response and Durability of Response
Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death
3 months after treatment and annually
Evaluate Immune Reconstitution
Evaluate immune reconstitution based on time to engraftment
3 months after treatment and annually
Study Arms (1)
2nd Stem Cell Transplant
EXPERIMENTALMobilization with filgrastim autologous stem cell transplantation with melphalan conditioning stem cell infusion
Interventions
16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection
infusion of previously collected stem cells on Day 0
infusion of previously collected stem cells on Day 0
Eligibility Criteria
You may qualify if:
- DISEASE CHARACTERISTICS:
- Histologically confirmed AL amyloidosis
- Persistent or recurrent disease after 1 course of prior high-dose chemotherapy
- Previously treated with autologous stem cell transplantation
- Significant initial improvement in organ function after prior high-dose melphalan, defined by at least 1 of the following:
- Complete hematologic remission (e.g., absence of monoclonal spike by immunofixation in serum and urine AND less then 5% plasma cells in bone marrow with no clonal predominance) OR partial hematologic response (e.g., any decrease in serum or urine monoclonal protein OR decrease in bone marrow plasmacytosis)
- Greater than 50% reduction in proteinuria with preservation of creatinine clearance
- Greater than 50% reduction in alkaline phosphatase OR at least 2 cm decrease in liver size by physical exam
- Subjective neurologic improvement, as confirmed by neurologist
- Cardiac stabilization of disease confirmed by echocardiography defined as less than 2 mm increase in mean wall thickness and/or less than 20 g increase in left ventricular mass
- Improvement in performance status\* NOTE: \*This criteria alone does not constitute significant improvement in organ function
- Prior stem cell yield must have been ≥ 2 x 10\^6 CD34+ cells/kg
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- +27 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston University Cancer Research Center
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principal Investigator
- Organization
- Boston Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Quillen, MD
Boston Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, Blood Bank
Study Record Dates
First Submitted
January 9, 2004
First Posted
January 12, 2004
Study Start
August 1, 2001
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
January 27, 2017
Results First Posted
January 27, 2017
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share