Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Peginterferon
Intervention description: Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

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 <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