Clinical trial NCT01241708: Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma
Official title: Tandem Autologous Hematopoietic Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Auto Stem Cell Transplant
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2010-11-16
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: lifetime
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: John Theurer Cancer Center @ Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: John Theurer Cancer Center at Hackensack University Medical Center
name: Michele Donato, MD
role: PRINCIPAL_INVESTIGATOR
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