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

Hackensack Meridian Health (Other)
Overall Status
Active, not recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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.

Study Design

Study Type:
Actual Enrollment :
146 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Tandem Autologous Hematopoietic Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma
Actual Study Start Date :
Apr 8, 2010
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Drug: Bortezomib
Bortezomib 1.6mg/m2 on day -4 and day -1
Other Names:
  • Velcade
  • Outcome Measures

    Primary Outcome Measures

    1. 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. [3 years]

    Secondary Outcome Measures

    1. 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. [lifetime]

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    Site City State Country Postal Code
    1 John Theurer Cancer Center @ Hackensack University Medical Center Hackensack New Jersey United States 07601

    Sponsors and Collaborators

    • Hackensack Meridian Health


    • Principal Investigator: Michele Donato, MD, John Theurer Cancer Center at Hackensack University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Hackensack Meridian Health
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • Pro00001295
    • NCT01374958
    First Posted:
    Nov 16, 2010
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Aug 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 26, 2021