Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Emory University
- New York University Cancer Institute
- Columbia Presbyterian Medical Center):
- Memorial Sloan-Kettering Cancer Center):
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
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
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.