Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Trial of Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant|
- engraftment kinetics [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]as measured by duration of neutropenia in patients with MM undergoing high-dose melphalan followed by fractionated CD34+ stem cell infusions.
- safety and toxicity profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]of high-dose melphalan therapy followed by multiple doses of CD34+ stem cell rescue in patients with MM. Whenever possible, the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 should be used to describe the event and for assessing the severity of AEs.
- neutrophil and platelet recovery rates. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Duration of neutropenia will be defined as the number of days ANC< 500x106/L. Time until platelet recovery (defined as platelets>=30x109/L), the number of units of red blood cells and platelets.
- incidence of infection [ Time Frame: 3 months post-SCT ] [ Designated as safety issue: Yes ]The incidence of infection by three months after re-infusion will be calculated.
- red cell and platelet transfusion requirements [ Time Frame: 2 years ] [ Designated as safety issue: No ]will be evaluated using the Spearman rank correlation coefficient
- duration of hospital admission [ Time Frame: 2 years ] [ Designated as safety issue: No ]length of hospital stay in days will be summarized using descriptive statistics.
- To assess symptom burden [ Time Frame: 2 years ] [ Designated as safety issue: No ]using the MSK Modified M.D. Anderson Symptom Inventory (MDASI).
- Multiple Myeloma response rates [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]at 3 months post-transplant according to standard response criteria. Response rates will be evaluated based on International Myeloma Working Group Uniform Response Criteria at 3 months following ASCT.
- correlation between engraftment kinetics and symptom burden [ Time Frame: 2 years ] [ Designated as safety issue: No ]in patients with MM who receive high-dose melphalan and fractionated CD34+ stem cell infusions
- the number of CD34+ cells/Kg present [ Time Frame: 2 years ] [ Designated as safety issue: No ]at the time of infusion. The difference between the number of CD34+ cells/kg given at each stem cell infusion time point and the number of CD34+ cells/kg before cryopreservation will be calculated as both a simple difference and percentage change.
- To correlate the number CD34+ cells/Kg given [ Time Frame: 2 years ] [ Designated as safety issue: No ]at the time of transplant with engraftment kinetics. The difference between the number of CD34+ cells/kg given at each stem cell infusion time point and the number of CD34+ cells/kg before cryopreservation will be calculated as both a simple difference and percentage change.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Fractionated Stem Cell Infusions
A single arm, open-label, single institution pilot trial is planned. Patients with chemosensitive MM and at least 7 x 10^6 CD34+ stem cells/kg (+/- 0.5 x 10^6 CD34+ stem cells/kg)available for use will be enrolled following initial induction or salvage therapy.
Procedure: Fractionated Stem Cell Infusions
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416246
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Heather Landau, MD||Memorial Sloan-Kettering Cancer Center|