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Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01273844
First Posted: January 11, 2011
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Soochow University
Nanjing Medical University
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
  Purpose
To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone) followed by autologous hematopoietic stem cell transplantation as an initial treatment in patients with newly diagnosed AL.

Condition Intervention
Amyloidosis Drug: Bortezomib

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in AL

Resource links provided by NLM:


Further study details as provided by Zhi-Hong Liu, M.D., Nanjing University School of Medicine:

Primary Outcome Measures:
  • Complete response rate [ Time Frame: 12 months ]
    Complete response rate at 12 months post-transplantation


Secondary Outcome Measures:
  • overall response rate [ Time Frame: 12 months ]
    overall response rate(ie.,CR + PR) at 12 months post-transplantation


Other Outcome Measures:
  • progression-free survival [ Time Frame: 2 years ]
    progression-free survival (PFS) at 2 years post-transplantation


Enrollment: 21
Actual Study Start Date: March 1, 2011
Study Completion Date: May 12, 2016
Primary Completion Date: May 12, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bortezomib
Patients will receive two 21-day cycles of induction therapy with vel / dex regimen. Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while Dexamethasone 40 mg/d will be taken orally on days 1-4.
Drug: Bortezomib
Bortezomib
Other Name: autologous hematopoietic stem cell transplantation

Detailed Description:

Patients will receive two 21-day cycles of induction therapy with vel / dex regimen. Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while Dexamethasone 40 mg/d will be taken orally on days 1-4. After two cycles of vel / dex therapy, the collection of peripheral blood stem cells (PBSC) should be completed within 4 weeks.Patients will receive ASCT therapy in 8 weeks after collection of PBSC (Recorded as day 0), while melphalan (day -2) with a dose of 100,140 or 200 mg/m2 (choosing a dose according to the degree of risk for patients ) and Vel 1mg/m2 (days -6, -3, +1, +4) will be given. Four additional 21-day cycles of Vel treatment (with a dose of 1.6mg/m2 on day 1 and 8 of the cycle) will be conducted as consolidation therapy during the recommended 60-90 days after HSCT, or after resumption of hematopoietic function ( neutrophil count > 1.5x109/L and platelet count> 50x109/L). Later patients won't need maintenance therapy.

The efficacy criteria are the international standards set with consensus of experts in the Tenth International Symposium on Amyloid and Amyloidosis.

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female;
  2. aged 18-65 years;
  3. Patients with newly diagnosed AL;
  4. Appropriate for autologous hematopoietic stem cell transplantation;
  5. Abnormal M protein or free light chain detected in serum and / or urine
  6. ECOG score 0-2 points;
  7. Subjects (or their legal representatives) must signed an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.

Exclusion Criteria:

  1. Subjects received systematic treatment with steroids
  2. Subjects received plasmapheresis to treat clinical significant hyperviscosity syndrome within 4 weeks before enrollment.
  3. Pregnant and breastfeeding women;
  4. Subjects suffering from multiple myeloma.
  5. hypersensitivity to dexamethasone, bortezomib, mannitol, boron, or heparin (if use catheters);
  6. Subjects have severe cardiovascular disease,
  7. Subjects have serious physical disease and mental illnesses which may interfere the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273844


Locations
China, Jiangsu
Soochow University
Suzhou, Jiangsu, China, 215325
Sponsors and Collaborators
Zhi-Hong Liu, M.D.
Soochow University
Nanjing Medical University
Investigators
Principal Investigator: zhihong Liu, Master Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China
  More Information

Responsible Party: Zhi-Hong Liu, M.D., professor, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT01273844     History of Changes
Other Study ID Numbers: NJCT-1006
First Submitted: January 3, 2011
First Posted: January 11, 2011
Last Update Posted: April 7, 2017
Last Verified: April 2017

Keywords provided by Zhi-Hong Liu, M.D., Nanjing University School of Medicine:
hematopoietic stem cell transplantation
amyloidosis
Bortezomib

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Dexamethasone
Bortezomib
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents