Alteration in Timing of Plerixafor Administration
Study Details
Study Description
Brief Summary
Typically, the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+ cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis (removal of blood) begins the following morning. The purpose of this study is to test whether plerixafor can instead be given 17 hours before apheresis. This timing would be more convenient since plerixafor would be given during normal clinic hours, and so patients would be within a clinic environment if any side effects develop.
The study will look for the activation of CD34+ cells in patients who receive plerixafor 17 hours before apheresis. We will follow the number of patients that achieve the target numbers of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the numbers in previous studies giving plerixafor 11 hours before apheresis.
We will also assess the safety of giving plerixafor 17 hours before apheresis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Plerixafor 17 hours prior to apheresis Dosing of plerixafor will occur at 3PM (1500 hours). |
Drug: Plerixafor
Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500. [Within the first 5 days following plerixafor initiation]
Secondary Outcome Measures
- Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs [Within the first 5 days following plerixafor initiation]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-70 years
-
MM patients in first or second complete or partial remission
-
ECOG performance status of 0 or 1
-
Up to 3 prior treatment regimens
-
Meet all eligibility requirements for autologous transplant
-
Adequate marrow function defined as WBC >3,000; ANC >1,500/mm3 ; Platelets >75,000/mm3
-
Adequate renal function defined as creatinine clearance > 30 mL/min by Cockcroft-Gault
-
Adequate liver function defined as AST/ALT/Bilirubin < 2 times upper limit of normal
-
Able to provide informed consent
-
Women not pregnant and agree to use contraception
Exclusion Criteria:
-
High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
-
Brain metastases or carcinomatous meningitis
-
Previous treatment with high dose chemotherapy and autologous transplant.
-
Previous attempt to collect B-HPCs following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors.
-
Acute infection or unexplained fever >38°C
-
Weight > 175% of ideal body weight as defined by the Devine equation.
-
Experimental therapy within 4 weeks
-
Cytokine administration in the previous 14 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
Sponsors and Collaborators
- Emory University
- Genzyme, a Sanofi Company
Investigators
- Principal Investigator: R. Donald Harvey, PharmD, FCCP, Emory University Winship Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00034057
- WCI1680-09
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Plerixafor 17 Hours Prior to Apheresis |
|---|---|
| Arm/Group Description | Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses. |
| Period Title: Overall Study | |
| STARTED | 34 |
| COMPLETED | 31 |
| NOT COMPLETED | 3 |
Baseline Characteristics
| Arm/Group Title | Plerixafor 17 Hours Prior to Apheresis |
|---|---|
| Arm/Group Description | Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses. |
| Overall Participants | 34 |
| Age, Customized (Years) [Median (Full Range) ] | |
| Median (Full Range) [Years] |
59
|
| Sex: Female, Male (Count of Participants) | |
| Female |
17
50%
|
| Male |
17
50%
|
| Region of Enrollment (participants) [Number] | |
| United States |
34
100%
|
Outcome Measures
| Title | Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500. |
|---|---|
| Description | |
| Time Frame | Within the first 5 days following plerixafor initiation |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Plerixafor 17 Hours Prior to Apheresis |
|---|---|
| Arm/Group Description | Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses. |
| Measure Participants | 31 |
| Number [Participants] |
31
91.2%
|
| Title | Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs |
|---|---|
| Description | |
| Time Frame | Within the first 5 days following plerixafor initiation |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Plerixafor 17 Hours Prior to Apheresis |
|---|---|
| Arm/Group Description | Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses. |
| Measure Participants | 31 |
| Number [Participants] |
22
64.7%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Plerixafor 17 Hours Prior to Apheresis | |
| Arm/Group Description | Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses. | |
All Cause Mortality |
||
| Plerixafor 17 Hours Prior to Apheresis | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Plerixafor 17 Hours Prior to Apheresis | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/31 (6.5%) | |
| Blood and lymphatic system disorders | ||
| Hypokalemia | 1/31 (3.2%) | |
| Musculoskeletal and connective tissue disorders | ||
| Bone Pain | 1/31 (3.2%) | |
Other (Not Including Serious) Adverse Events |
||
| Plerixafor 17 Hours Prior to Apheresis | ||
| Affected / at Risk (%) | # Events | |
| Total | 26/31 (83.9%) | |
| Blood and lymphatic system disorders | ||
| hypokalemia | 7/31 (22.6%) | |
| Gastrointestinal disorders | ||
| Diarrhea | 5/31 (16.1%) | |
| General disorders | ||
| Nausea | 11/31 (35.5%) | |
| Dizziness | 4/31 (12.9%) | |
| Musculoskeletal and connective tissue disorders | ||
| Bone Pain | 16/31 (51.6%) | |
| Surgical and medical procedures | ||
| Injection site reactions | 10/31 (32.3%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Harvey |
|---|---|
| Organization | Emory University |
| Phone | 404-778-4381 |
| rdharve@emory.edu |
- IRB00034057
- WCI1680-09