Status:
COMPLETED
Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This phase III randomized trial compares three different peripheral stem cell mobilization regimens for patients with multiple myeloma who have received primary induction therapy or other therapies. U...
Detailed Description
PRIMARY STUDY OBJECTIVES • To compare the efficacy of the following peripheral stem cell mobilization regimens for MM: i. High dose cyclophosphamide, VELCADE, and G-CSF ii. VELCADE and G-CSF iii. Hig...
Eligibility Criteria
Inclusion
- Voluntary written informed consent
- Confirmed diagnosis of multiple myeloma
- Age \> than 18 years at the time of signing the informed consent form.
- Karnofsky performance status above 60%
- Patients must be within 30 days of completing induction therapy.
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control .
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Life expectancy \> 12 weeks.
- Subjects must have a MUGA scan or echo with LVEF \>50%
- Subjects must meet the following laboratory parameters:
- Absolute neutrophil count (ANC) ≥1500 cells/mm3
- Platelets count ≥ 50,000/mm3
- Hemoglobin \> 9.0 g/dL
- Serum SGOT/AST \<3.0 x upper limits of normal (ULN)
- Serum SGPT/ALT \<3.0 x upper limits of normal (ULN)
- Serum creatinine \< 2.5 mg/dL or creatinine clearance \> 40ml/min
- Serum total bilirubin \< 1.5 x ULN
Exclusion
- Patients with (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan.
- History of allergic reactions to compounds containing boron, mannitol, VELCADE
- Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for \> = 5 years.
- NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, severe uncontrolled cardiac arrhythmia, electrocardiographic evidence of acute ischemia, active conduction system abnormalities or myocardial infarction within 6 months prior to enrollment. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
- Known HIV or hepatitis A, B, or C positivity---ONLY IF ACTIVE
- Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk
- Patient has \> = Grade 2 peripheral neuropathy within 14 days before enrollment.
- Patient has received other investigational drugs with 14 days before enrollment
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2019
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01146834
Start Date
March 1 2011
End Date
February 4 2019
Last Update
December 27 2019
Active Locations (5)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
New York University Cancer Institute
New York, New York, United States, 10016
3
Columbia Presbyterian Medical Center):
New York, New York, United States, 10032
4
Memorial Sloan-Kettering Cancer Center):
New York, New York, United States, 10065