NCT00396383 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2014-03-13

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Participant Counts of Summarized Adverse Events (AE) During Treatment

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants with MM who were eligible for autologous peripheral blood stem cell transplantation.
intervention Names
Drug: plerixafor
label
Participants with Multiple Myeloma (MM)
type
EXPERIMENTAL

interventions

arm Group Labels
Participants with Multiple Myeloma (MM)
description
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.
name
plerixafor
other Names
Mozobil
AMD3100
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 9
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg
time Frame
Day 1 up to day 4
description
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).
measure
Participant Counts of Summarized Adverse Events (AE) During Treatment
time Frame
1 month

secondary Outcomes

description
Polymorphonuclear cell (PMN) engraftment was defined as a PMN count ≥ 0.5\*10\^9/L for 3 consecutive days or ≥ 1\*10\^9/L for 1 day. Days to engraftment corresponded to the first day that the criteria were met after transplantation.
measure
Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment
time Frame
Approximately 2 months
description
Platelet (PLT) engraftment was defined as a PLT count of ≥ 20\*10\^9/L for 7 days without transfusion. Days to engraftment corresponded to the first day that the criteria were met after transplantation.
measure
Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment
time Frame
Approximately 2 months
description
Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation.
measure
Number of Participants With a Durable Graft at 12 Months Post Transplantation
time Frame
Approximately month 13

Full study description

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.
detailed Description: 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 240 µg/kg 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 engraftment will be assessed for a minimum of one year. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Source references

references

citation
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.
type
RESULT
citation
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
type
RESULT

Source notices and limitations

Discovery and provenance

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source url
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Preserved source evidence · Not medical advice