Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant

NCT01416246 | Completed

• 1 other identifier: 11-105
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Keywords

Stem cell Infusions; Autologous Stem Cell Transplant; 11-105

Outcome Measures

Primary Outcomes (1)

• engraftment kinetics

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

  2 years

Secondary Outcomes (10)

• safety and toxicity profile

  2 years

• neutrophil and platelet recovery rates.

  2 years

• incidence of infection

  3 months post-SCT

• red cell and platelet transfusion requirements

  2 years

• duration of hospital admission

  2 years

Study Arms (1)

Fractionated Stem Cell Infusions

EXPERIMENTAL

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

Interventions

Fractionated Stem Cell Infusions PROCEDURE

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.

Also known as: 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.

Fractionated Stem Cell Infusions

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Erythrocyte Count; Platelet Transfusion; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Blood Component Transfusion; Blood Transfusion; Biological Therapy

Study Officials

• Heather Landau, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 12, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 29, 2016

Record last verified: 2016-04

Locations

US (1)