peginterferon α-2b as a maintenance therapy in participants with multiple myeloma who responded to induction therapy (p01972-am7)

Conditions: Multiple Myeloma

Summary: this study aims to assess the efficacy of peginterferon α-2b, compared to a control arm not receiving any maintenance treatment, in adult subjects with multiple myeloma who have responded to a prior induction therapy. peginterferon α-2b will be given once weekly as an injection until disease progression or relapse, or for up to a maximum of 5 years (whichever occurs first).


Eligibility criteria:
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 \ 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