A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
2 other identifiers
interventional
205
1 country
1
Brief Summary
The goal of this clinical research study is to compare Busulfex (busulfan) with or without Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in patients who will receive an autologous stem cell transplant. The safety of this combination therapy will also be studied. Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2011
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2011
CompletedFirst Posted
Study publicly available on registry
August 10, 2011
CompletedStudy Start
First participant enrolled
September 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2019
CompletedResults Posted
Study results publicly available
April 21, 2020
CompletedApril 21, 2020
April 1, 2020
7.4 years
August 8, 2011
February 17, 2020
April 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
Participants that are still alive and without Multiple Myeloma 3 years after Stem cell Transplantation.
3 years after transplant
Secondary Outcomes (4)
Number of Participants With Complete Response (CR)
Evaluated 90 days from transplant.
Treatment-Related Mortality (TRM) Between 2 Arms.
100 days post treatment
Number of Participants That Had Grade 3-4 Toxicities.
At day 90 post SCT (Stem Cell Transplantation)
Overall Survival (OS)
From time of ASCT to 3 years
Study Arms (2)
Busulfan + Melphalan
EXPERIMENTALBusulfan test dose (32 mg/m\^2) on day -9 then 130 mg/m\^2 intravenous (IV) Days -7, -6, -5, and -4 + Melphalan 70 mg/m2 IV on Days -2 and -1. Stem Cell Transplant (SCT) Day 0.
Melphalan
EXPERIMENTALHigh-dose Melphalan 200 mg/m2/day IV over 30 minutes on day -2. SCT Day 0.
Interventions
Test dose (32 mg/m\^2) on day -9 then 130 mg/m\^2 by vein or adjusted dose on Days -7, -6, -5, and -4.
70 mg/m2 by vein over 30 minutes minutes on Days -2 and -1.
Quality of Life (QOL) questionnaire before starting the study drugs and then once every 4 weeks after the stem cell transplant, taking about 15 minutes to complete.
Approximately 5 mcg/kg/day subcutaneously beginning on Day +5.
Stem cell infusion on Day 0.
Eligibility Criteria
You may qualify if:
- Patients with multiple myeloma in complete remission (CR), partial remission (PR), or very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain MM detected in the serum by free light chain assay.
- Patients with non-secretory multiple myeloma \[absence of a monoclonal protein (M protein) in serum as measured by electrophoresis (SPEP) and immunofixation (SIFE) and the absence of Bence Jones protein in the urine (UPEP) defined by use of conventional electrophoresis and immunofixation (UIFE) techniques\] but with measurable disease on imaging studies like MRI, CT scan or PET scan.
- Who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy.
- years of age or younger.
- Karnofsky performance score 70% or higher.
- Cardiac function: left ventricular ejection fraction at rest \> 40% within 3 months of registration.
- Hepatic function: bilirubin \< 2x the upper limit of normal and ALT and AST \< 2.5x the upper limit of normal.
- Renal function: creatinine clearance of \>/= 40 mL/min, estimated or calculated.
- Pulmonary function: DLCO, FEV1, FVC \>/= 50% of predicted value (corrected for hemoglobin) within 3 months of registration
- Signed informed consent form.
You may not qualify if:
- Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
- Patients seropositive for the human immunodeficiency virus (HIV).
- Patients with history of myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Patients participating in an investigational new drug protocol within 14 days before enrollment.
- Female patients who are pregnant (positive b-HCG) or breastfeeding.
- Prior stem cell transplantation allogeneic or autologous.
- Prior organ transplant requiring immunosuppressive therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Bashir Q, Thall PF, Milton DR, Fox PS, Kawedia JD, Kebriaei P, Shah N, Patel K, Andersson BS, Nieto YL, Valdez BC, Parmar S, Rondon G, Delgado R, Hosing C, Popat UR, Oran B, Ciurea SO, Lin P, Weber DM, Thomas SK, Lee HC, Manasanch EE, Orlowski RZ, Williams LA, Champlin RE, Qazilbash MH. Conditioning with busulfan plus melphalan versus melphalan alone before autologous haemopoietic cell transplantation for multiple myeloma: an open-label, randomised, phase 3 trial. Lancet Haematol. 2019 May;6(5):e266-e275. doi: 10.1016/S2352-3026(19)30023-7. Epub 2019 Mar 22.
PMID: 30910541DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Muzaffar H. Qazilbash / Stem Cell Transplantation and Cellular Therapy
- Organization
- U.T. MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Muzaffar H. Qazilbash, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2011
First Posted
August 10, 2011
Study Start
September 30, 2011
Primary Completion
March 10, 2019
Study Completion
March 10, 2019
Last Updated
April 21, 2020
Results First Posted
April 21, 2020
Record last verified: 2020-04