Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Peginterferon α-2b
No Treatment
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
Participants will be observed and will receive no treatment.