Status:
COMPLETED
Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT00732641
Start Date
December 1 2000
End Date
November 1 2010
Last Update
April 4 2017
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