Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: bortezomib (Velcade); cyclophosphamide; G-CSF; Plerixafor
Intervention description: 1.3 mg/m2 IVP on days 1, 4, 8 and 11; 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C); given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D); plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
Intervention MeSH terms: Plerixafor; Cyclophosphamide; Bortezomib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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. 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
    

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:

               1. Absolute neutrophil count (ANC) ≥1500 cells/mm3

               2. Platelets count ≥ 50,000/mm3

               3. Hemoglobin > 9.0 g/dL

               4. Serum SGOT/AST <3.0 x upper limits of normal (ULN)

               5. Serum SGPT/ALT <3.0 x upper limits of normal (ULN)

               6. Serum creatinine < 2.5 mg/dL or creatinine clearance > 40ml/min

               7. 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.