Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

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. Up to 180 patients will be enrolled. Patients eligible for treatment will be randomized to one of the three following mobilization regimens: Arm A = VELCADE, CYCLOPHOSPHAMIDE, \& G-CSF Arm B = VELCADE \& G-CSF Arm C = CYCLOPHOSPHAMIDE \& G-CSF Arm D = PLERIXAFOR \& G-CSF Arm E = PLERIXAFOR, VELCADE, \& G-CSF

Key facts

Study ID

NCT01146834

Run by

Weill Medical College of Cornell University

People needed

47

Starts

2011-03-01

Expected to finish

2019-02-04

Last updated by the study team

2019-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Emory University — Atlanta, Georgia, United States
• New York University Cancer Institute — New York, New York, United States
• Columbia Presbyterian Medical Center): — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center): — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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