We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 August 2017 by Hackensack University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01241708
First Posted: November 16, 2010
Last Update Posted: August 9, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hackensack University Medical Center
November 15, 2010
November 16, 2010
August 9, 2017
April 8, 2010
February 2023   (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 ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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
Experimental: Tandem Transplantation with Melphalan and Bortezomib
Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma
Intervention: Drug: Bortezomib

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
142
February 2023
February 2023   (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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Michele Donato, MD 551-996-5900 Michele.Donato@HackensackMeridian.org
United States
 
 
NCT01241708
Pro00001295
Yes
Not Provided
Not Provided
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 2017

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