Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)

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)

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).

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