AMD3100 (Plerixafor) Given to NHL and MM Patients to Increase the Number of PBSCs When Given a Mobilizing Regimen of G-CSF

NCT00396266 | Completed Phase 2 Results DMC

• 1 other identifier: AMD3100-C201
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN) engraftment after transplantation. Data from this protocol will assist in the determination of the dosing schedule for future studies.

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin

Keywords

Non-Hodgkin's Lymphoma; Multiple Myeloma; stem cell mobilization; AMD3100; autologous transplantation

Outcome Measures

Primary Outcomes (1)

• Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)

  Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').

  Day 1 to approximately Day 38 (before start of chemotherapy)

Secondary Outcomes (10)

• Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells

  Time 0 to 11 hours after the first dose of plerixafor

• Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant

  2 months

• Tumor Cell Mobilization in Non-Hodgkin's Lymphoma (NHL) Participants Following Plerixafor Treatment

  Prior to the first (Day 4) and last dose of plerixafor, immediately prior to each apheresis, and 24 hours after the last apheresis.

• Single-dose Maximum Observed Concentration of Plerixafor (Cmax)

  Day 5 - 0 to 10 hours post-first plerixafor dose.

• Single-dose Time to Maximum Concentration of Plerixafor (Tmax)

  Day 5 - 0 to 10 hours post-first plerixafor dose

Study Arms (2)

Non-Hodgkin's Lymphoma (NHL)

EXPERIMENTAL

Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

Drug: G-CSF Plus Plerixafor

Multiple Myeloma (MM)

EXPERIMENTAL

Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

Drug: G-CSF Plus Plerixafor

Interventions

G-CSF Plus Plerixafor DRUG

Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

Also known as: Mozobil, AMD3100

Multiple Myeloma (MM); Non-Hodgkin's Lymphoma (NHL)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myoloma (MM) eligible for autologous transplantation
• No more than 3 prior regimens of chemotherapy
• More than 4 weeks since last cycle of chemotherapy. Patient recovered from all acute toxic effects of prior chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• White blood cell (WBC) count \>3.0\*10\^9/L
• Absolute polymorphonuclear cells (PMN) count \>1.5\*10\^9/L
• Platelet (PLT) count \>100\*10\^9/L
• Serum creatinine \<=2.2 mg/dL
• Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin \<2 x upper limit of normal (ULN)
• Left ventricle ejection fraction \>45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan
• Forced expiratory volume of the lung in the first second (FEV1) \>60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) \>45% of predicted
• Negative for human immunodeficiency virus (HIV) type 1
• Women of child bearing potential agreed to use an approved form of contraception.

You may not qualify if:

• Patients who have failed previous collections
• Brain metastases or carcinomatous meningitis
• History of ventricular arrhythmias
• A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications
• A residual acute medical condition resulting from prior chemotherapy
• Acute infection
• Fever (temp \>38°C/100.4°F)
• Patients whose actual body weight exceeds 150% of their ideal body weight
• History of paresthesias (at least Grade 2)
• Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period
• Positive pregnancy test in female patients
• Lactating females
• Patients of child-bearing potential unwilling to implement adequate birth control.
• Patients who have deterioration of their clinical status or laboratory parameters between the time of enrolment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal investigator, or sponsor.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (2)

Tom Baker Cancer Center

Calgary, Alberta, T2N 4N2, Canada

Location

Vancouver General Hospital, BC Cancer Agency

Vancouver, British Columbia, V5Z 4E3, Canada

Location

Related Publications (1)

• Stewart DA, Smith C, MacFarland R, Calandra G. Pharmacokinetics and pharmacodynamics of plerixafor in patients with non-Hodgkin lymphoma and multiple myeloma. Biol Blood Marrow Transplant. 2009 Jan;15(1):39-46. doi: 10.1016/j.bbmt.2008.10.018.

  PMID: 19135941 RESULT

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin

Interventions

Granulocyte Colony-Stimulating Factor; plerixafor

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; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Genzyme Medical Information
• Organization: Genzyme Corporation

800-745-4447

Study Officials

• Medical Monitor, MD

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 6, 2006
• Study Start: January 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 7, 2014
• Results First Posted: November 25, 2010

Record last verified: 2014-02

Locations

CA (2)