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Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma ((Mel/MelVel))

This study is currently recruiting participants.
Verified May 2013 by Hackensack University Medical Center
Sponsor:
Information provided by (Responsible Party):
Hackensack University Medical Center
ClinicalTrials.gov Identifier:
NCT01241708
First received: November 15, 2010
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

High dose chemotherapy with stem cell transplantation is commonplace in the treatment of multiple myeloma. This treatment uses a chemotherapy drug called Melphalan that has been used in several thousand bone marrow transplant recipients worldwide for the same or similar disorders. Many patients with multiple myeloma receive 2 stem cell transplantations within a few months of each other as part of their treatment. Usually the drug Melphalan is used for both transplants.

Bortezomib is a drug that is used for treating multiple myeloma and has been used in combination with melphalan for stem cell transplantation for patients with multiple myeloma.

The purpose of this trial is to study the effects of doing 2 transplants, first using melphalan and second using melphalan and bortezomib. The trial is aiming to find out if adding the Bortezomib to the second transplant will increase the chances of staying in remission longer.


Condition Intervention Phase
Multiple Myeloma
Auto Stem Cell Transplant
 Drug: Bortezomib
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tandem Autologous Hematopoietic Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hackensack University Medical Center:

Primary Outcome Measures:
  • To determine the progression-free survival of patients with multiple myeloma treated with tandem cycles of high-dose melphalan followed by high-dose melphalan in combination with bortezomib with autologous HSC transplantation. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the response rate, overall survival, and regimen-related toxicities of patients with multiple myeloma treated with high-dose melphalan or high-dose melphalan in combination with bortezomib given in tandem transplants. [ Time Frame: lifetime ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: April 2010
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bortezomib
    Bortezomib 1.6mg/m2 on day -4 and day -1
    Other Name: Velcade
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of multiple myeloma ISS stage I, II or III, less than 12 months since initiation of systemic therapy
  • ≥8x106 CD34+cells/kg available in cryopreservation in aliquots appropriate for tandem transplants
  • Age: 18-75 years at time of transplantation
  • KPS 70-100%
  • Recovery from complications of prior therapies
  • Gender: There is no gender restriction

Exclusion Criteria:

  • Diagnosis other than multiple myeloma
  • Chemotherapy or radiotherapy within 21 days of initiating treatment in this study
  • Prior autologous or allogeneic transplantation (except as enrolled into this study)
  • Uncontrolled bacterial, viral, fungal or parasitic infections
  • Uncontrolled CNS metastases
  • Known amyloid deposition in heart
  • Organ dysfunction
  • LVEF <40% or cardiac failure not responsive to therapy
  • FVC, FEV1, or DLCO <50% of predicted and/or receiving supplementary continuous oxygen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241708

Contacts
Contact: Michele Donato, MD MDonato@humed.com

Locations
United States, New Jersey
John Theurer Cancer Center @ Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Emily Brown, RN     551-996-3923     EmilyBrown@hackensackUMC.org    
Contact: Ann Marie Maguire, RN     551-336-8213     AMaguire@hackensackUMC.org    
Principal Investigator: Michele Donato, MD            
Sponsors and Collaborators
Hackensack University Medical Center
Investigators
Principal Investigator: Michele Donato, MD John Theurer Cancer Center at Hackensack University Medical Center
  More Information

No publications provided

Responsible Party: Hackensack University Medical Center
ClinicalTrials.gov Identifier: NCT01241708     History of Changes
Obsolete Identifiers: NCT01374958
Other Study ID Numbers: Pro00001295
Study First Received: November 15, 2010
Last Updated: May 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
 Melphalan
Bortezomib
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013