High-Dose Melphalan and Stem Cell Transplant in Treating Patients With Immunoglobulin Deposition Disease or Light-Chain Deposition Disease
This study is currently recruiting participants.
Verified November 2012 by Boston Medical Center
Sponsor:
Boston Medical Center
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00681044
First received: May 18, 2008
Last updated: November 27, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer 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 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 the side effects of high-dose melphalan given together with stem cell transplant and to see how well it works in treating patients with immunoglobulin deposition disease or light-chain deposition disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: filgrastim 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: | HIGH-DOSE MELPHALAN AND AUTOLOGOUS STEM CELL TRANSPLANTATION (HDM/SCT) IN LIGHT-CHAIN DEPOSITION DISEASE (LCDD) AND IMMUNOGLOBULIN DEPOSITION DISEASE (IGDD) |
Resource links provided by NLM:
Drug Information available for:
Melphalan
Melphalan hydrochloride
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by Boston Medical Center:
Primary Outcome Measures:
- Tolerability [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
- Hematologic response rate [ Time Frame: one year ] [ Designated as safety issue: No ]
- Predictability of early free light-chain response for heme response [ Time Frame: one month ] [ Designated as safety issue: No ]
- Organ or clinical response [ Time Frame: one year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: life ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | February 2030 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: filgrastim
16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
Other Name: G-CSF, neulasta
Drug: melphalan
70-100 mg/m2/day will be administered intravenously on Days -3 and -2
Other Name: alkeran
Procedure: autologous hematopoietic stem cell transplantation
infusion of previously collected stem cells on Day 0
OBJECTIVES:
- To assess the tolerability of high-dose melphalan and autologous stem cell transplantation in patients with immunoglobulin deposition disease or light-chain deposition disease.
- To determine the hematologic response rate in patients treated with this regimen.
- To determine the predictability of early free light-chain response for heme response in patients treated with this regimen.
- To determine organ or clinical response in patients treated with this regimen.
- To determine overall survival of these patients.
OUTLINE:
- Stem cell mobilization: Patients undergo blood stem cell mobilization comprising filgrastim (G-CSF) subcutaneously once daily for 3 days (i.e., through the day before the last stem cell collection).
- Stem cell collection: Patients undergo collection of G-CSF-mobilized blood stem cells until the target number of stem cells (at least 2 x 10^6 CD34+ cells) is reached.
- Conditioning regimen: Patients receive high-dose melphalan IV on days -3 to -2.
- Autologous stem cell transplantation: Patients undergo blood stem cell infusion on day 0.
After completion of study therapy, patients are followed at 3, 6, and 12 months and then annually thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed light-chain deposition disease based on the following criteria:
- Deposition of granular material containing free light-chain (FLC) immunoglobulins that did not bind Congo red
Evidence of a plasma cell dyscrasia, as defined by any of the following:
- Monoclonal gammopathy in the serum or urine by immunofixation electrophoresis
- Clonal plasmacytosis on bone marrow biopsy by IHC
- Elevated serum levels of FLC
No overt multiple myeloma, as defined by any of the following:
- Greater than 30% bone marrow plasmacytosis
- Extensive (i.e., > 2) lytic lesions
- Hypercalcemia
- Patients may enroll after stem cell collection (SCC) if all prestudy requirements are completed prior to starting SCC (i.e., ≥ 2.5 x 10^6 cells available for transplantation)
PATIENT CHARACTERISTICS:
- Performance status 0-2
- LVEF ≥ 45% within the past 90 days
- No myocardial infarction, congestive heart failure, or arrhythmia refractory to therapy within the past 6 months
- No prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer from which the patient is currently in complete response, or any other cancer from which the patient has been disease-free for the past 5 years
- No HIV positivity
- DLCO ≥ 50%
PRIOR CONCURRENT THERAPY:
- Prior chemotherapy with alkylating agent allowed provided there is no evidence of myelodysplastic syndromes
- Prior total dose of melphalan < 300 mg
- More than 4 weeks since prior cytotoxic therapy and recovered
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681044
Locations
| United States, Massachusetts | |
| Boston University Cancer Research Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Clinical Trials Office - Boston University Cancer Research Cen 617-638-8265 | |
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: | NCT00681044 History of Changes |
| Other Study ID Numbers: | CDR0000595782, BHO-H-25876, BUMC-H-25876 |
| Study First Received: | May 18, 2008 |
| Last Updated: | November 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Boston Medical Center:
|
monoclonal immunoglobulin deposition disease light chain deposition disease |
Additional relevant MeSH terms:
|
Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma 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 |
Immunoglobulins Antibodies Melphalan Lenograstim Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Myeloablative Agonists Immunosuppressive Agents Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 22, 2013