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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02489500
Other study ID # H-33808
Secondary ID VelRand
Status Terminated
Phase Phase 3
First received
Last updated
Start date June 2015
Est. completion date April 28, 2017

Study information

Verified date August 2018
Source Boston Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Standard treatment for AL Amyloidosis is high-dose melphalan and stem cell transplant.

This study will compare the safety and effectiveness of standard treatment with high-dose melphalan and stem cell transplant, compared with investigational bortezomib when used in combination with standard treatment with high-dose melphalan and stem cell transplant for AL amyloidosis.


Description:

This study seeks to enroll patients with AL amyloidosis who have been recommended for standard treatment with high-dose melphalan and stem cell transplant.

Standard treatment for this disease is high-dose melphalan and stem cell transplant.

The purpose of this study is to compare the safety and effectiveness of standard treatment with high-dose melphalan and stem cell transplant, compared with investigational bortezomib when used in combination with standard treatment with high-dose melphalan and stem cell transplant for AL amyloidosis.

Patients enrolled in this study will receive either standard treatment with high-dose melphalan and stem cell transplant, or investigational bortezomib used in combination with standard treatment with high-dose melphalan and stem cell transplant.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date April 28, 2017
Est. primary completion date April 28, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Histological diagnosis of primary systemic (AL) amyloidosis based on:

- Deposition of amyloid material by Congo red stain showing characteristic apple green birefringence,AND…

- evidence of a clonal plasma cell dyscrasia with monoclonal protein in the serum or urine by immunofixation electrophoresis studies AND/OR abnormal serum free light chain assay AND/OR clonal plasma cells in the bone marrow exam demonstrated by immunohistochemistry, flow cytometry or in situ hybridization AND…

- evidence of organ involvement other than carpal tunnel syndrome. Patients with senile, secondary, localized, dialysis-related or familial amyloidosis are not eligible. Confirmation of tissue diagnosis at all sites of organ dysfunction is encouraged, but not required.

2. Patients must be > 18 years of age.

3. Patients must have a performance status of 0-2 by Eastern Cooperative Oncology Group (ECOG) criteria

4. Patients must have left ventricular ejection fraction (LVEF) > 45% by echocardiogram within 60 days of enrollment

5. Pulmonary Function Tests must show diffusing capacity of lung for carbon monoxide (DLCO) > 50%.

6. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

1. Patients with recent (< 6 months) myocardial infarction, congestive heart failure, New York Heart Association (NYHA) class III/IV or arrhythmia which are refractory to medical therapy are ineligible.

2. Prior chemotherapy with alkylating agent allowed only if no evidence of Myelodysplastic Dysplastic Syndrome (MDS) morphologically or cytogenetically. Total cumulative dose of oral melphalan must be < 300 mg. Patients should not have received any cytotoxic therapy < 4 weeks prior to registration and should have fully recovered from the effects of such therapy.

3. Patients must not have overt multiple myeloma (>30% bone marrow plasmacytosis and, extensive (>2) lytic lesions and hypercalcemia).

4. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

5. Patients must not be HIV positive.

6. Pregnant or nursing women may not participate. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bortezomib
Conditioning Regimen: Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1
Melphalan
Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0
Neupogen
granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days
Procedure:
Stem Cell Collection
collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells
Stem cell infusion
infusion of previously collected autologous stem cells

Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Hematologic Response Hematologic response defined as: at least 50% improvement in the difference between involved and uninvolved free light chains 6 months
Secondary Toxicities Number of serious adverse events per participant based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 100 days
Secondary Overall Survival duration of overall survival measured in days 5 years
Secondary Number of Participants With Organ Response analysis of number of patients with organ response, as defined on page 13 of the detailed protocol for kidney, heart and liver. 5 years
See also
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Completed NCT02574676 - Quality of Life (QOL) Registry for Patients With AL Amyloidosis
Recruiting NCT06065852 - National Registry of Rare Kidney Diseases
Active, not recruiting NCT05199337 - Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis Phase 1/Phase 2
Recruiting NCT01758042 - Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders N/A
Completed NCT01409148 - Radioimmunoimaging of AL Amyloidosis Phase 1
Active, not recruiting NCT04512235 - A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis Phase 3
Recruiting NCT06383143 - Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
Recruiting NCT05277493 - A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab
Completed NCT02632786 - The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Phase 2
Completed NCT02841033 - Daratumumab for the Treatment of Patients With AL Amyloidosis Phase 1/Phase 2
Completed NCT04304144 - A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis Phase 2
Recruiting NCT01408225 - Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
Recruiting NCT04895917 - Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis Phase 2
Completed NCT01570387 - A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis Phase 1/Phase 2
Terminated NCT03154047 - Study in Subjects With Light Chain (AL) Amyloidosis Phase 2
Completed NCT03236792 - Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis Phase 1/Phase 2
Recruiting NCT04392960 - Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis N/A
Recruiting NCT05898646 - Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial Phase 2
Not yet recruiting NCT06022939 - Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis Phase 3