Phase III Randomized, Prospective Multi-center Trial of PEG-Interferon α-2b as a Maintenance Therapy, Compared to Observation, in Patients With Multiple Myeloma Who Responded to Induction Therapy (Protocol No P01972)
Inclusion Criteria:
- Must demonstrate willingness to participate in the study and to adhere to dose and
visit schedules
- Must be ≤85 years of age of either sex, and any race
- Must have stage II or III multiple myeloma with a histological confirmation
consistent with the diagnosis of multiple myeloma (by biopsy of an osteolytic or soft
tissue tumour composed of plasma cells or bone marrow aspirate and/or biopsy
demonstrating ≥ 10% plasmacytosis). The histological confirmation should have been
obtained prior to the induction chemotherapy or bone marrow transplant chemotherapy
- May not have received prior interferon for the treatment of multiple myeloma
- Must confirm that he/she is practicing adequate contraception
- If a female volunteer of childbearing potential, must have a negative serum
pregnancy test at Screening/Visit 1
- Must be free of any clinically relevant disease (other than multiple myeloma) that
would, in the principal investigator's and/or sponsor's opinion, interfere with the
conduct of the study or study evaluations
- Must be able to adhere to the dosing and visit schedules
- Clinical laboratory tests (complete blood chemistry [CBC], blood chemistries,
urinalysis) must be consistent with adequate hepatic and renal function, defined as
<2 times upper limit of any laboratory normal (ULN) and adequate hematological
functions defined as platelets > 50,000/mm^3, Hemoglobin ≥9.0 g/dL, white blood count
(WBC) count ≥2000/mm^3
- Must have a complete, partial or minimal response after either one induction
chemotherapy regimen or one myelosuppressive chemotherapeutic treatment followed by
peripheral blood stem cell infusion as a first line treatment. Any type of
pre-transplant chemotherapy and conditioning regimen is allowed
- Performance Status Karnofsky score of ≥60% at time of randomization
Exclusion Criteria:
- Is a female who is pregnant, or intends to become pregnant during the study
- Is nursing, or intends to be nursing during the study
- Has used any investigational product within 30 days prior to enrollment
- Have any of the following clinical conditions:
- Pre existing psychiatric condition, especially depression, or a history of
severe psychiatric disorder, such as major psychoses, suicidal ideation and/or
suicidal attempt. Subjects with a history of mild depression may be considered
for entry into the protocol provided that a pre-treatment assessment of the
subject's mental status indicates that the subject is clinically stable and that
there is ongoing evaluation of the patient's mental status during the study
- Central Nervous System (CNS) trauma or active seizure disorders requiring
medication
- Significant cardiovascular dysfunction within the previous 6 months before the
study starts (eg, angina, congestive heart failure, recent myocardial
infarction, severe hypertension or significant arrhythmia) or patient with
multigated acquisition (MUGA) or echocardiogram < 40%;
- History of prior malignant disease within the previous 5 years before the study
starts, except for surgically cured squamous cell or basal cell skin carcinoma
or Stage I cervical carcinoma or cervical carcinoma in situ;
- Known severe coagulation disorders, thrombophlebitis or pulmonary embolism or
decompensate liver disease;
- Uncontrolled diabetes mellitus or thyroid dysfunction (not responsive to
therapy);
- Severe chronic pulmonary disease (eg, chronic obstructive pulmonary disease);
- Has active and/or uncontrolled infection
- Is in a situation or condition that, in the opinion of the investigator, may
interfere with optimal participation in the study
- Is participating in any other clinical study
- Is on the staff, affiliated with, or a family member of the staff personnel directly
involved with this study
- Is allergic to or has sensitivity to the study drug or its excipients