Status:
COMPLETED
Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma
Lead Sponsor:
Hackensack Meridian Health
Conditions:
Multiple Myeloma
Auto Stem Cell Transplant
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 thousa...
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. Bortezo...
Eligibility Criteria
Inclusion
- Changed from:
- 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
- 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
Key Trial Info
Start Date :
April 8 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2023
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01241708
Start Date
April 8 2010
End Date
July 15 2023
Last Update
September 17 2025
Active Locations (1)
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1
John Theurer Cancer Center @ Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601