Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional

Summary: 
      Multiple myeloma is difficult to treat with only anti-cancer medicine (called chemotherapy)
      or radiation alone. Sometimes higher doses of chemotherapy are used but when used can also
      lower blood counts. Using own cells (special cells called stem cells) to help increase the
      blood counts after high doses of chemotherapy is called autologous stem cell transplantation
      (ASCT).

      Using own stem cells to restore blood counts and other advances in supportive measures
      (antibiotics and growth factors that increase blood counts) has improved the safety of ASCT.
      However, blood counts still decrease for a period of days after high doses of chemotherapy.
      During that time, patients are at greater risk for infections. Studies have shown that the
      faster the blood counts recover after ASCT, the less at risk there is for developing unwanted
      side effects after ASCT.

      Typically during an ASCT, a patient's stem cells are given back to them all at once on a
      single day. In this study, the investigators plan to see what happens when smaller amounts of
      own stem cells are given back to the patient over multiple days. The investigators want to
      find out what effects good and/or bad this will have on the patient and there multiple
      myeloma. Some studies have shown that giving back stem cells over a period of days helps to
      increase bone marrow activity and decrease the time it takes for blood counts to recover
      after ASCT. It is our hope that this new approach may lower a patient's risk of side effects
      and infections, decrease the number of blood transfusions that a patient needs during this
      process, reduce the time a patient has to spend in the hospital, and lower overall treatment
      costs.
    


Intervention name(s): Fractionated Stem Cell Infusions
Intervention type(s): Procedure
Intervention description(s): Following enrollment patients will be treated with melphalan intravenously (IV) through a central venous catheter (CVC) over 30 minutes at 200mg/m2 or 140mg/m2 (if creatinine clearance is < or = to 50 and/or age > 70 years) on day -2. Following 24 hours of rest, the first dose of CD34+ stem cell will be administered on day 0 (2.5-5 x 106 CD 34+ stem cells/kg)+/- 0.5 x 106 CD34+ stem cells/kg), followed by 3 additional doses of CD 34+ stem cells (1.5-2.5 x 106 CD 34+ stem cells/kg)+/- 0.5 x 106 CD34+ stem cells/kg) on days +2, +4, and +6. Pegfilgrastim 6μg will be administered on day +1. Filgrastim 5μg/kg will be 12-24 hours after the 2nd-4th stem cell infusions. There will be a +/- 1 day window for the Day +2, +4, and +6 infusions to accommodate infusions that occur over the weekend or on holidays.
Other intervention name(s): Patients will receive standard supportive care measures (including; antimicrobial prophylaxis, red blood cell and platelet transfusions and; treatment for neutropenic fever) as per institutional practices. Neutrophil; engraftment is defined as absolute neutrophil count (ANC) > or = to 500 x 10^6/L for 2; consecutive days.
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stem cell Infusions; Autologous Stem Cell Transplant; 11-105