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. (see Contacts and Locations)
Verified August 2014 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: August 28, 2014
Last verified: August 2014

November 15, 2010
August 28, 2014
April 2010
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01241708 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma
Tandem Autologous Hematopoietic Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma

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.

Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Auto Stem Cell Transplant
Drug: Bortezomib
Bortezomib 1.6mg/m2 on day -4 and day -1
Other Name: Velcade
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
May 2015
December 2014   (final data collection date for primary outcome measure)

Changed from: Inclusion Criteria:

  • Confirmed diagnosis of multiple myeloma with either Durie-Salmon stage I, II, or III or 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 8 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
Both
18 Years to 75 Years
No
Contact: Michele Donato, MD MDonato@humed.com
United States
 
NCT01241708
Pro00001295
Yes
Hackensack University Medical Center
Hackensack University Medical Center
Not Provided
Principal Investigator: Michele Donato, MD John Theurer Cancer Center at Hackensack University Medical Center
Hackensack University Medical Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP