Status:
UNKNOWN
Busulfan, Melphalan, Escalating Carfilzomib Conditioning Auto Stem Cell Transplantation for Multiple Myeloma (MM)
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Amgen
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
In this protocol, the investigators hypothesize that the combination of intravenous busulfan and melphalan with carfilzomib will be an effective preparative regimen with acceptable toxicity for partic...
Detailed Description
Participants enrolled in this study protocol will receive daily intravenous (IV) infusions of carfilzomib for a total of 4 days (Day-9, -8 and Days -2, -1). The first two daily infusions will be given...
Eligibility Criteria
Inclusion
- Participants must be greater than or equal to 18 years of age.
- Participants must have been diagnosed with multiple myeloma in a first or subsequent remission and have undergone a successful pre-transplant work up and are otherwise eligible for an autotransplant with a busulfan/melphalan preparative regimen at Loyola University Medical Center.
- Participants may receive this preparative regimen if in first or subsequent remission. Participants may enter if they have received a prior autologous stem cell transplant and this therapy produced a remission that lasted greater than 18 months before progression of disease. Participants who have undergone prior allogeneic transplantation are excluded.
- All participants must have responsive disease as defined by a Partial Response or greater to most recent conventional regimen.
- Participants receiving prior carfilzomib will be eligible for inclusion provided they demonstrated responsive disease to this agent and either had a remission that lasted greater than 6 months after its discontinuance, or if in remission after a carfilzomib containing regimen administered to qualify for transplant.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) less than or equal to 2.
- Acceptable heart function test.
Exclusion
- Participants must not have below normal kidney function.
- Participants must not have below normal liver function.
- Participants must not have active bacterial, fungal, or viral infection.
- Participants must not have severe lung function.
- Participants must not have Grade 2 or greater peripheral neuropathy.
- Participants must not have uncontrolled hypertension.
Key Trial Info
Start Date :
May 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03795597
Start Date
May 22 2019
End Date
November 1 2023
Last Update
April 26 2021
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153