Multiple MyelomaNCT01416246
Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant
A study testing Fractionated Stem Cell Infusions in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Fractionated Stem Cell Infusions
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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%.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Pilot Trial of 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.
- Conditions
- Multiple Myeloma
- Being tested
- Fractionated Stem Cell Infusions
- Keywords
- Stem cell Infusions, Autologous Stem Cell Transplant, 11-105
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated Stem Cell InfusionsProcedure or surgery
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Fractionated Stem Cell Infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
engraftment kinetics
as measured by duration of neutropenia in patients with MM undergoing high-dose melphalan followed by fractionated CD34+ stem cell infusions.
Measured: 2 years
Secondary outcomes (10)
safety and toxicity profile
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.
Measured: 2 years
neutrophil and platelet recovery rates.
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.
Measured: 2 years
incidence of infection
The incidence of infection by three months after re-infusion will be calculated.
Measured: 3 months post-SCT
red cell and platelet transfusion requirements
will be evaluated using the Spearman rank correlation coefficient
Measured: 2 years
duration of hospital admission
length of hospital stay in days will be summarized using descriptive statistics.
Measured: 2 years
To assess symptom burden
using the MSK Modified M.D. Anderson Symptom Inventory (MDASI).
Measured: 2 years
Multiple Myeloma response rates
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.
Measured: at 3 months
correlation between engraftment kinetics and symptom burden
in patients with MM who receive high-dose melphalan and fractionated CD34+ stem cell infusions
Measured: 2 years
the number of CD34+ cells/Kg present
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.
Measured: 2 years
To correlate the number CD34+ cells/Kg given
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Landau, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416246
- Sponsor's protocol ID
- 11-105
- Status last verified
- Apr 2016
- First submitted
- 11 Aug 2011
- Last updated
- 29 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT01416246
- Acronym / sponsor ID
- 11-105
- Conditions
- Multiple Myeloma
- Keywords
- Stem cell Infusions, Autologous Stem Cell Transplant, 11-105
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractionated Stem Cell Infusions | Experimental | Procedure: Fractionated Stem Cell InfusionsA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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):
- To be calculated by the Cockroft-Gault method: (140-Age) x Mass (kg) x [0.85 if female] (72 x Creatinine (mg/dL)
- Performance status KPS > or = to 70%.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractionated Stem Cell InfusionsAlso: 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 2Following 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. | Procedure or surgery | Fractionated Stem Cell Infusions |
Primary outcome
engraftment kinetics
Time frame: 2 years
as measured by duration of neutropenia in patients with MM undergoing high-dose melphalan followed by fractionated CD34+ stem cell infusions.
10 secondary outcomes
safety and toxicity profile
Time frame: 2 years
neutrophil and platelet recovery rates.
Time frame: 2 years
incidence of infection
Time frame: 3 months post-SCT
red cell and platelet transfusion requirements
Time frame: 2 years
duration of hospital admission
Time frame: 2 years
To assess symptom burden
Time frame: 2 years
Multiple Myeloma response rates
Time frame: at 3 months
correlation between engraftment kinetics and symptom burden
Time frame: 2 years
the number of CD34+ cells/Kg present
Time frame: 2 years
To correlate the number CD34+ cells/Kg given
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Landau, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated Stem Cell Infusions in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
engraftment kinetics (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.