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Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection

Primary Purpose

Myeloma, Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Plerixafor
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myeloma focused on measuring Myeloma, Lymphoma, Stem cell transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-70 years
  2. Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Up to 3 prior treatment regimens
  5. Meet all eligibility requirements for autologous transplant
  6. Adequate marrow function defined as white blood cells (WBC) >3,000; ANC >1,500/mm3; platelets >75,000/mm3
  7. Adequate renal function defined as creatinine clearance > 30 mL/min by Cockcroft-Gault
  8. Adequate liver function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin < 2 times upper limit of normal
  9. Able to provide informed consent
  10. Women not pregnant and agree to use contraception

Exclusion Criteria:

  1. High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
  2. Brain metastases or carcinomatous meningitis
  3. Previous treatment with high dose chemotherapy and autologous transplant
  4. Previous attempt to collect B-hematopoietic progenitor cells (HPCs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors
  5. Acute infection or unexplained fever >38°C
  6. Weight > 175% of ideal body weight as defined by the Devine equation
  7. Experimental therapy within 4 weeks
  8. Cytokine administration in the previous 14 days

Sites / Locations

  • Emory University Winship Cancer Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Plerixafor + Chemo and G-CSF

Arm Description

Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.

Outcomes

Primary Outcome Measures

Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis
Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg

Secondary Outcome Measures

Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)

Full Information

First Posted
March 26, 2010
Last Updated
September 16, 2014
Sponsor
Emory University
Collaborators
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01095757
Brief Title
Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection
Official Title
Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor. The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloma, Lymphoma
Keywords
Myeloma, Lymphoma, Stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plerixafor + Chemo and G-CSF
Arm Type
Other
Arm Description
Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Intervention Type
Drug
Intervention Name(s)
Plerixafor
Other Intervention Name(s)
Mozobil, AMD3100
Intervention Description
240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
Primary Outcome Measure Information:
Title
Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis
Time Frame
Within the first 4 days following the first dose of Plerixafor
Title
Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg
Time Frame
Within the first 4 days following the first dose of Plerixafor
Secondary Outcome Measure Information:
Title
Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)
Time Frame
Within the first 4 days following the first dose of Plerixafor

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-70 years Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission Eastern Cooperative Oncology Group (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 white blood cells (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 aspartate aminotransferase (AST)/alanine aminotransferase (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-hematopoietic progenitor cells (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmund Waller, MD, PhD
Organizational Affiliation
Emory University Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11313668
Citation
Lazarus HM, Loberiza FR Jr, Zhang MJ, Armitage JO, Ballen KK, Bashey A, Bolwell BJ, Burns LJ, Freytes CO, Gale RP, Gibson J, Herzig RH, LeMaistre CF, Marks D, Mason J, Miller AM, Milone GA, Pavlovsky S, Reece DE, Rizzo JD, van Besien K, Vose JM, Horowitz MM. Autotransplants for Hodgkin's disease in first relapse or second remission: a report from the autologous blood and marrow transplant registry (ABMTR). Bone Marrow Transplant. 2001 Feb;27(4):387-96. doi: 10.1038/sj.bmt.1702796.
Results Reference
background
PubMed Identifier
10733490
Citation
Lemoli RM, Martinelli G, Zamagni E, Motta MR, Rizzi S, Terragna C, Rondelli R, Ronconi S, Curti A, Bonifazi F, Tura S, Cavo M. Engraftment, clinical, and molecular follow-up of patients with multiple myeloma who were reinfused with highly purified CD34+ cells to support single or tandem high-dose chemotherapy. Blood. 2000 Apr 1;95(7):2234-9.
Results Reference
background
PubMed Identifier
16682719
Citation
Smith TJ, Khatcheressian J, Lyman GH, Ozer H, Armitage JO, Balducci L, Bennett CL, Cantor SB, Crawford J, Cross SJ, Demetri G, Desch CE, Pizzo PA, Schiffer CA, Schwartzberg L, Somerfield MR, Somlo G, Wade JC, Wade JL, Winn RJ, Wozniak AJ, Wolff AC. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006 Jul 1;24(19):3187-205. doi: 10.1200/JCO.2006.06.4451. Epub 2006 May 8.
Results Reference
background
PubMed Identifier
2478216
Citation
Siena S, Bregni M, Brando B, Ravagnani F, Bonadonna G, Gianni AM. Circulation of CD34+ hematopoietic stem cells in the peripheral blood of high-dose cyclophosphamide-treated patients: enhancement by intravenous recombinant human granulocyte-macrophage colony-stimulating factor. Blood. 1989 Nov 1;74(6):1905-14.
Results Reference
background
PubMed Identifier
11498739
Citation
Cassens U, Momkvist PH, Zuehlsdorf M, Mohr M, Kienast J, Berdel WE, Sibrowski W. Kinetics of standardized large volume leukapheresis (LVL) in patients do not show a recruitment phenomenon of peripheral blood progenitor cells (PBPC). Bone Marrow Transplant. 2001 Jul;28(1):13-20. doi: 10.1038/sj.bmt.1703082.
Results Reference
background
PubMed Identifier
15104662
Citation
Koenigsmann M, Jentsch-Ullrich K, Mohren M, Becker E, Heim M, Franke A. The role of diagnosis in patients failing peripheral blood progenitor cell mobilization. Transfusion. 2004 May;44(5):777-84. doi: 10.1111/j.0041-1132.2004.03321.x.
Results Reference
background
PubMed Identifier
17381621
Citation
Hicks ML, Lonial S, Langston A, Flowers C, Roback JD, Smith KJ, Mossavi Sai S, Teagarden D, Hamilton ES, Waller EK, Kaufman J. Optimizing the timing of chemotherapy for mobilizing autologous blood hematopoietic progenitor cells. Transfusion. 2007 Apr;47(4):629-35. doi: 10.1111/j.1537-2995.2007.01164.x. Erratum In: Transfusion. 2007 May;47(5):952. Kaufman, Jonathan [added].
Results Reference
background
PubMed Identifier
21492180
Citation
Li J, Hamilton E, Vaughn L, Graiser M, Renfroe H, Lechowicz MJ, Langston A, Prichard JM, Anderson D, Gleason C, Lonial S, Flowers CR, Kaufman JL, Waller EK. Effectiveness and cost analysis of "just-in-time" salvage plerixafor administration in autologous transplant patients with poor stem cell mobilization kinetics. Transfusion. 2011 Oct;51(10):2175-82. doi: 10.1111/j.1537-2995.2011.03136.x. Epub 2011 Apr 14.
Results Reference
background
PubMed Identifier
17581613
Citation
Kumar S, Dispenzieri A, Lacy MQ, Hayman SR, Buadi FK, Gastineau DA, Litzow MR, Fonseca R, Roy V, Rajkumar SV, Gertz MA. Impact of lenalidomide therapy on stem cell mobilization and engraftment post-peripheral blood stem cell transplantation in patients with newly diagnosed myeloma. Leukemia. 2007 Sep;21(9):2035-42. doi: 10.1038/sj.leu.2404801. Epub 2007 Jun 21.
Results Reference
background
PubMed Identifier
18033320
Citation
Mazumder A, Kaufman J, Niesvizky R, Lonial S, Vesole D, Jagannath S. Effect of lenalidomide therapy on mobilization of peripheral blood stem cells in previously untreated multiple myeloma patients. Leukemia. 2008 Jun;22(6):1280-1; author reply 1281-2. doi: 10.1038/sj.leu.2405035. Epub 2007 Nov 22. No abstract available.
Results Reference
background
PubMed Identifier
18216870
Citation
Paripati H, Stewart AK, Cabou S, Dueck A, Zepeda VJ, Pirooz N, Ehlenbeck C, Reeder C, Slack J, Leis JF, Boesiger J, Torloni AS, Fonseca R, Bergsagel PL. Compromised stem cell mobilization following induction therapy with lenalidomide in myeloma. Leukemia. 2008 Jun;22(6):1282-4. doi: 10.1038/sj.leu.2405100. Epub 2008 Jan 24. No abstract available.
Results Reference
background
PubMed Identifier
21282380
Citation
Christopher MJ, Rao M, Liu F, Woloszynek JR, Link DC. Expression of the G-CSF receptor in monocytic cells is sufficient to mediate hematopoietic progenitor mobilization by G-CSF in mice. J Exp Med. 2011 Feb 14;208(2):251-60. doi: 10.1084/jem.20101700. Epub 2011 Jan 31.
Results Reference
background
PubMed Identifier
11104786
Citation
Ponomaryov T, Peled A, Petit I, Taichman RS, Habler L, Sandbank J, Arenzana-Seisdedos F, Magerus A, Caruz A, Fujii N, Nagler A, Lahav M, Szyper-Kravitz M, Zipori D, Lapidot T. Induction of the chemokine stromal-derived factor-1 following DNA damage improves human stem cell function. J Clin Invest. 2000 Dec;106(11):1331-9. doi: 10.1172/JCI10329.
Results Reference
background
PubMed Identifier
16337237
Citation
Jung Y, Wang J, Schneider A, Sun YX, Koh-Paige AJ, Osman NI, McCauley LK, Taichman RS. Regulation of SDF-1 (CXCL12) production by osteoblasts; a possible mechanism for stem cell homing. Bone. 2006 Apr;38(4):497-508. doi: 10.1016/j.bone.2005.10.003. Epub 2005 Dec 5.
Results Reference
background
PubMed Identifier
19363221
Citation
DiPersio JF, Stadtmauer EA, Nademanee A, Micallef IN, Stiff PJ, Kaufman JL, Maziarz RT, Hosing C, Fruehauf S, Horwitz M, Cooper D, Bridger G, Calandra G; 3102 Investigators. Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood. 2009 Jun 4;113(23):5720-6. doi: 10.1182/blood-2008-08-174946. Epub 2009 Apr 10.
Results Reference
background
PubMed Identifier
22624594
Citation
Kaufman JL, Flowers CR, Rados KD, Calandra GB, Vose JM, Hewes LB, Lonial S, Langston AA, Khoury HJ, Lechowicz MJ, Waller EK. A prospective clinical trial evaluating the safety and efficacy of the combination of rituximab and plerixafor as a mobilization regimen for patients with lymphoma. Transfusion. 2013 Jan;53(1):76-84. doi: 10.1111/j.1537-2995.2012.03719.x. Epub 2012 May 25.
Results Reference
background

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Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection

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