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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Multiple Myeloma

Treatments

Drug: Peginterferon

Study type

Interventional

Funder types

Industry

Identifiers

NCT00732641

P01972

Details and patient eligibility

About

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).

Enrollment

244 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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