Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: plerixafor
Intervention description: Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later. Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4*10^6 CD34+ cells/kg body weight had been collected.
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Stem cell mobilization; apheresis

Summary:

      This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and
      well tolerated in multiple myeloma (MM) patients. In addition, this study determines if
      plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for
      transplantation in MM patients. The minimum number of CD34+ cells to collect is 2*10^6 CD34+
      cells/kg and the target is ≧4*10^6 CD34+ cells/kg. Success of transplant engraftment will be
      measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT)
      engraftment. Durability of transplant will be assessed for a minimum of one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of multiple myeloma (MM)

          -  Eligible for autologous transplantation

          -  Patients in first or second partial remission (PR) or complete remission (CR)

          -  Patients who have received ≦2000 rads of prior radiation therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Recovered from all acute toxic effects of prior chemotherapy

          -  White blood cells (WBC) >3.0*10^9/l

          -  Absolute polymorphonuclear leucocyte (PMN) count >1.5*10^9/l

          -  Platelet (PLT) count > 150*10^9/l

          -  Serum creatinine ≦2.2 mg/dl

          -  Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase
             (SGPT) and total bilirubin <2 x upper limit of normal (ULN)

          -  Negative for HIV

          -  Signed informed consent

          -  Patients of childbearing potential agree to use an approved form of contraception

        Exclusion Criteria:

          -  Patient received 2 or more alkylating agents, such as VBMCP (a combination of
             Vincristine, BCNU (Bis-Chloronitrosourea), Melphalan, Cyclophosphamide, and
             Prednisone)

          -  Patient received a total dose of ≧200 mg of prior melphalan

          -  A co-morbid condition which, in the view of the investigators, renders the patient at
             high risk from treatment complications

          -  Patient has failed previous collections or collection attempts

          -  A residual acute medical condition resulting from prior chemotherapy

          -  Brain metastases or carcinomatous meningitis

          -  Acute infection

          -  Fever (temperature >38 °C / 100.4 °F)

          -  Hypercalcemia (>1mg/dl above ULN)

          -  Positive pregnancy test in female patients

          -  Lactating females

          -  Patients of childbearing potential unwilling to implement adequate birth control

          -  Patients whose actual body weight exceeds 175% of their ideal body weight

          -  History of ventricular arrhythmias

          -  Patient received thalidomide within 10 days prior to receiving the first dose of
             plerixafor

          -  Patients who previously received experimental therapy within 4 weeks of enrolling in
             this protocol or who are currently enrolled in another experimental protocol during
             the mobilization phase