Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation

NCT00396383 | Terminated Phase 2 Results DMC

• 1 other identifier: AMD3100-2108
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2\*10\^6 CD34+ cells/kg and the target is ≧4\*10\^6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of transplant will be assessed for a minimum of one year.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Stem cell mobilization; apheresis

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg

  Number of participants achieving a target of ≥ 4\*10\^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Target was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.

  Day 1 up to day 4

• Participant Counts of Summarized Adverse Events (AE) During Treatment

  Participant counts of summarized adverse events (AEs) which occurred from the first dose of plerixafor up to the day prior to chemotherapy/ablative treatment. Events were graded according to World Health Organization criteria: Mild (awareness of sign or symptom, but easily tolerated), Moderate (discomfort enough to cause interference with usual activity), Severe (incapacitating with inability to work or do usual activity).

  1 month

Secondary Outcomes (3)

• Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment

  Approximately 2 months

• Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment

  Approximately 2 months

• Number of Participants With a Durable Graft at 12 Months Post Transplantation

  Approximately month 13

Study Arms (1)

Participants with Multiple Myeloma (MM)

EXPERIMENTAL

Participants with MM who were eligible for autologous peripheral blood stem cell transplantation.

Drug: plerixafor

Interventions

plerixafor DRUG

Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later. Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4\*10\^6 CD34+ cells/kg body weight had been collected.

Also known as: Mozobil, AMD3100

Participants with Multiple Myeloma (MM)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of multiple myeloma (MM)
• Eligible for autologous transplantation
• Patients in first or second partial remission (PR) or complete remission (CR)
• Patients who have received ≦2000 rads of prior radiation therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Recovered from all acute toxic effects of prior chemotherapy
• White blood cells (WBC) \>3.0\*10\^9/l
• Absolute polymorphonuclear leucocyte (PMN) count \>1.5\*10\^9/l
• Platelet (PLT) count \> 150\*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)
• Negative for HIV
• Signed informed consent
• Patients of childbearing potential agree to use an approved form of contraception

You may not qualify if:

• Patient received 2 or more alkylating agents, such as VBMCP (a combination of Vincristine, BCNU (Bis-Chloronitrosourea), Melphalan, Cyclophosphamide, and Prednisone)
• Patient received a total dose of ≧200 mg of prior melphalan
• A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications
• Patient has failed previous collections or collection attempts
• A residual acute medical condition resulting from prior chemotherapy
• Brain metastases or carcinomatous meningitis
• Acute infection
• Fever (temperature \>38 °C / 100.4 °F)
• Hypercalcemia (\>1mg/dl above ULN)
• Positive pregnancy test in female patients
• Lactating females
• Patients of childbearing potential unwilling to implement adequate birth control
• Patients whose actual body weight exceeds 175% of their ideal body weight
• History of ventricular arrhythmias
• Patient received thalidomide within 10 days prior to receiving the first dose of plerixafor

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead
• AnorMED: collaborator

Study Sites (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• Flomenberg N, Comenzo R, Badel K, Calandra G. Single agent AMD3100 mobilization of peripheral blood progenitor cells for autologous transplantation in patients with multiple myeloma (MM) [abstract]. Blood. Nov 16 2006;108(11 Pt 1):965a.

  RESULT

• Flomenberg N, Comenzo RL, Badel K, Calandra G. Plerixafor (Mozobil) alone to mobilize hematopoietic stem cells from multiple myeloma patients for autologous transplantation. Biol Blood Marrow Transplant. 2010 May;16(5):695-700. doi: 10.1016/j.bbmt.2009.12.538. Epub 2010 Jan 11.

  PMID: 20067838 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

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

Limitations and Caveats

Study had limited enrollment prior to termination.

Results Point of Contact

• Title: Genzyme Medical Information
• Organization: Genzyme Corporation

800-745-4447

Study Officials

• Medical Monitor

  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: NON 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: November 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: March 13, 2014
• Results First Posted: October 21, 2010

Record last verified: 2014-02

Locations

US (2)