Trial record 1 of 2 for:
27277
Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Boston Medical Center.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Boston Medical Center
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00790647
First received: November 12, 2008
Last updated: June 12, 2012
Last verified: June 2011
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Purpose
RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the growth of abnormal cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy and monoclonal antibody therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib followed by stem cell transplant works in treating patients with primary systemic amyloidosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: filgrastim Drug: bortezomib Drug: melphalan Procedure: autologous hematopoietic stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL Amyloidosis |
Resource links provided by NLM:
Drug Information available for:
Melphalan
Melphalan hydrochloride
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Bortezomib
U.S. FDA Resources
Further study details as provided by Boston Medical Center:
Primary Outcome Measures:
- Hematologic response (complete and partial) [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tolerability [ Time Frame: 100 Days from transplant date ] [ Designated as safety issue: Yes ]
- Survival at 1 and 2 years [ Time Frame: year one and two ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: filgrastim
16 mcg/kg daily beginning 3 days before SCC through day before final SCC
Other Name: G-CSF, neupogen
Drug: bortezomib
1.0 mg/m2/dose D -6, D-3, D +1, D + 4
Other Name: velcade
Drug: melphalan
100 mg/m2/dose D -2, D -1
Other Name: alkeran
Procedure: autologous hematopoietic stem cell transplantation
infusion of previously collected autologous stem cells
OBJECTIVES:
- To determine if hematologic responses to high-dose melphalan and autologous stem cell transplantation increase with addition of bortezomib in the conditioning regimen in patients with primary systemic amyloidosis.
OUTLINE:
- Autologous stem cell mobilization and collection: Patients receive filgrastim (G-CSF) to mobilize stem cells, which are then collected.
- Conditioning regimen: Patients receive bortezomib IV on days -6, -3, 1, and 4 and oral high-dose melphalan on days -2 and -1.
- Stem cell transplantation: Patients undergo autologous stem cell transplantation on day 0.
After completion of study therapy, patients are followed every 6 months for 1 year and annually thereafter.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed primary systemic amyloidosis based on the following criteria:
- Amyloid light-chain disease
- Deposition of amyloid material by congo red stain showing characteristic green birefringence
- Monoclonal light chain protein (Bence Jones protein) in the serum or urine, immunohistochemical studies, or serum free light chain assay
- Evidence of tissue involvement other than carpal tunnel syndrome (i.e., positive immunohistochemical staining of bone marrow demonstrating clonal plasma cells); tissue amyloid deposits with anti-kappa or anti-lambda anti-serum; evidence for a PCD by serum/urine or bone marrow; or overwhelmingly convincing clinical features (e.g., macroglossia) associated with other systemic manifestations
- No senile, secondary, localized, dialysis-related, or familial amyloidosis
- No overt multiple myeloma (> 30% of bone marrow plasmacytosis, extensive [> 2] lytic lesions, or hypercalcemia)
PATIENT CHARACTERISTICS:
- SWOG performance status 0-1
- Not pregnant or nursing
- Fertile patients must use effective contraception
- LVEF ≥ 45% by ECHO within the past 60 days
- DLCO ≥ 50%
- No myocardial infarction within the past 6 months, congestive heart failure, or arrhythmia refractory to therapy
No prior malignancy except for any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer currently in complete remission
- Any cancer from which the patient has been disease-free ≥ 5 years
- No advanced (grade 3-4) pre-existing neuropathy
- No HIV positivity
PRIOR CONCURRENT THERAPY:
- Prior chemotherapy with alkylating agent allowed provided there is no morphological or cytogenetic evidence of myelodysplastic syndromes
- Prior total cumulative dose of oral melphalan < 300 mg
- At least 4 weeks since prior cytotoxic therapy and fully recovered
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790647
Locations
| United States, Massachusetts | |
| Boston University Cancer Research Center | |
| Boston, Massachusetts, United States, 02118 | |
Sponsors and Collaborators
Boston Medical Center
Investigators
| Principal Investigator: | Vaishali Sanchorawala, MD | Boston Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT00790647 History of Changes |
| Other Study ID Numbers: | CDR0000618857, BUMC-H-27277 |
| Study First Received: | November 12, 2008 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Boston Medical Center:
|
primary systemic amyloidosis |
Additional relevant MeSH terms:
|
Amyloidosis Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Proteostasis Deficiencies Metabolic Diseases Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Melphalan Bortezomib Lenograstim Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents |
ClinicalTrials.gov processed this record on June 17, 2013