Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT01074060
Eligibility Criteria:
Criteria
* Inclusion and exclusion criteria must be re-evaluated prior to dosing with PLERIXAFOR; if the patient does not meet any of these criteria (excluding the hepatic and hematologic criteria) the patient is not eligible to continue unless Genzyme grants a waiver
Inclusion
* Eligible to undergo autologous transplantation
* Diagnosed with multiple myeloma (MM)
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
* The patient has recovered from all acute toxic effects of prior chemotherapy
* White Blood Count (WBC) \> 2.5 x 10\^9/L
* Absolute neutrophil count \>1.5 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Serum creatinine \<= 2.5 mg/dl
* Creatinine clearance \>= 50 ml/min (measured or calculated)
* Serum glutamic oxaloacetic transaminase (SGOT) \< 2 x ULN (Upper Limit of Normal)
* Serum glutamic pyruvic transaminase (SGPT) \< 2 x ULN
* Total bilirubin \< 2 x ULN
* Left ventricle ejection fraction \> 45% \[by normal ECHO (Echocardiogram) or MUGA (MUltiple Gated Acquisition) scan\]
* FEV1 (forced expiratory volume in 1 second) \> 60% of predicted or DLCO (Carbon Monoxide Diffusing Capacity )\> 55% of predicted
* No active infection of hepatitis B or C
* Negative for HIV
* Signed informed consent (may be obtained anytime prior to admission for cytoxan)
* Women of child bearing potential agree to use an approved form of contraception
Exclusion
* A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications
* A residual acute medical condition resulting from prior chemotherapy
* Brain metastases or carcinomatous meningitis
* Acute infection
* Fever (temp \> 38 degrees C/100.4 degrees F)
* Positive pregnancy test in female patients
* Lactating females
* Patients of child-bearing potential unwilling to implement adequate birth control
* Prior treatment with Plerixafor
* Prior stem cell transplant, either autologous or allogeneic
* Prior cyclophosphamide priming
* Heart rate \< 50 at screening
* Abnormal ECG (electrocardiogram) with a clinically significant rhythm disturbance or conduction abnormality that in the opinion of the investigator warrants exclusion of the subject from the trial
* Patients with congestive heart failure at screening
* History of atrial fibrillation
* Patients who are currently on medication to control cardiac arrhythmias
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01074060
Study Brief:
Protocol Section:
NCT01074060