Busulfan Plus Melphalan Versus Melphalan
This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01413178
First received: August 8, 2011
Last updated: April 15, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myeloma |
Drug: Busulfan Drug: Melphalan Other: Questionnaire Drug: G-CSF Drug: High Dose Melphalan Procedure: Stem cell transplant |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Busulfan
Melphalan
Melphalan hydrochloride
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Number of Participants with Complete Response (CR) [ Time Frame: Evaluated 90 days from transplant. ] [ Designated as safety issue: No ]Complete response (CR), evaluated 90 days from transplant, defined as (i) negative immunofixation of the multiple myeloma (MM) protein in urine and serum, (ii) disappearance of any soft tissue plasmacytomas, and (iii) less than 5% plasma MM cells in the bone marrow. International Myeloma Working Group uniform response criteria.
| Estimated Enrollment: | 190 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Busulfan + Melphalan
Busulfan 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.
|
Drug: Busulfan
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.
Other Names:
Drug: Melphalan
70 mg/m2 by vein over 30 minutes minutes on Days -2 and -1.
Other Name: Alkeran
Other: Questionnaire
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.
Other Name: Survey
Drug: G-CSF
Approximately 5 mcg/kg/day subcutaneously beginning on Day +5.
Other Names:
Procedure: Stem cell transplant
Stem cell infusion on Day 0.
Other Names:
|
|
Experimental: Melphalan
High-dose Melphalan 200 mg/m2/day IV over 30 minutes on day -2.
|
Other: Questionnaire
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.
Other Name: Survey
Drug: G-CSF
Approximately 5 mcg/kg/day subcutaneously beginning on Day +5.
Other Names:
Drug: High Dose Melphalan
200 mg/m2 by vein over 30 minutes on Day -2.
Other Name: Alkeran
Procedure: Stem cell transplant
Stem cell infusion on Day 0.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- 70 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413178
Contacts
| Contact: Muzaffar H. Qazilbash, MD | 713-792-8750 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
| Principal Investigator: | Muzaffar H. Qazilbash, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01413178 History of Changes |
| Other Study ID Numbers: | 2010-0071 |
| Study First Received: | August 8, 2011 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Myeloma Multiple Myeloma Light chain Multiple Myeloma MM Autologous Hematopoietic Stem Cell Transplantation Busulfan Busulfex Myleran Melphalan |
Alkeran G-CSF Filgrastim NeupogenTM Questionnaire Survey Quality of Life QOL |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
Busulfan Melphalan Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 21, 2013