Know Cancer

or
forgot password

Pilot Trial of Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant


N/A
18 Years
75 Years
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

Pilot Trial of Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant


Inclusion Criteria:



- Age ≥18 and < than or = to 75

- Histologic and serologic findings, reviewed at MSKCC, confirming the diagnosis of
multiple myeloma. Standard diagnostic criteria for multiple myeloma will be used, as
per the International Myeloma Foundation consensus guidelines (Durie et al, 2003) .

- Patients must have symptomatic multiple myeloma who have responded to prior induction
or salvage chemotherapy (i.e. chemosensitive disease):

- Patients who are receiving high-dose melphalan and ASCT as part of their initial
therapy require at least minor response to their last line of therapy to
document chemosensitive disease (Anderson et al. 2008)

- Patients who are receiving high-dose melphalan and ASCT as part of salvage
therapy require at least a minor response to their last line of therapy to
document chemosensitive disease (Anderson et al. 2008).

- There is no limit on the number of prior regimens received by the patient.

- Patients must have at least 7 x 10^6 (+/- 0.5 x 10^6) CD34+ stem cells/kg
frozen if he/she is being treated as part of a salvage (second) transplant
strategy; patients must have 10 x 10^6 (+/- 0.5 x 10^6) CD34+ stem cells/kg
frozen if ASCT is being performed as part of initial therapy.

- Adequate organ function is required, defined as follows:

- Serum bilirubin ≤ 2.0 mg/dl

- AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal

- Creatinine clearance > or = to 40 ml/min (24 hour urine collection or
calculated*)

*To be calculated by the Cockroft-Gault method: (140-Age) x Mass (kg) x [0.85 if
female] (72 x Creatinine (mg/dL)

- LVEF > or = to 45% by MUGA or rest ECHO

- Diffusing capacity > or = to 45% (adjusted for hemoglobin) predicted by
pulmonary function testing

- Performance status KPS > or = to 70%.

Exclusion Criteria:

- Unstable angina or myocardial infarction within 4 months of initiating therapy on
trial, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled
ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of
acute ischemia or Grade 3 conduction system abnormalities unless subject has a
pacemaker

- Pregnant or lactating females

- Nonhematologic malignancy within the past 3 years with the exception of a) adequately
treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b)
carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or
less with stable prostate-specific antigen levels; or d) cancer considered cured by
surgical resection or unlikely to impact survival during the duration of the study,
such as localized transitional cell carcinoma of the bladder or benign tumors of the
adrenal or pancreas

- Contraindication to melphalan or any of the required supportive treatments, including
hypersensitivity to G-CSF or pegfilgrastim

- Any other medical condition or laboratory evaluation that, in the treating
physician's or principal investigator's opinion, makes the patient unsuitable to
participate in this clinical trial

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

engraftment kinetics

Outcome Description:

as measured by duration of neutropenia in patients with MM undergoing high-dose melphalan followed by fractionated CD34+ stem cell infusions.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Heather Landau, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-105

NCT ID:

NCT01416246

Start Date:

August 2011

Completion Date:

August 2015

Related Keywords:

  • Multiple Myeloma
  • Stem cell Infusions
  • Autologous Stem Cell Transplant
  • 11-105
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021