NCT00732641CompletedPhase 3
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 244
- Primary Endpoint
- Number of Days With Progression Free Survival (PFS)
Study Overview
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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Peginterferon α-2b
Experimental
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
Intervention: Peginterferon (Drug)
Outcomes
Primary Outcomes
Number of Days With Progression Free Survival (PFS)
Time Frame: Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)
PFS was defined as response duration while on maintenance therapy. It was the length of time during and after treatment in which a participant was living with the cancer that did not get worse. PFS was calculated from the date of randomization to the date of the first documented tumor progression or relapse.
Secondary Outcomes
- Number of Days of Overall Survival (OS)(Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse))
- Number of Participants With Minimal Response (MR) to Treatment(Month 9 & Month 18)
- Quality of Life(Screening and Last Observation (up to 5 years))
- Number of Participants With Partial Response (PR) to Treatment(Month 9 & Month 18)
- Number of Participants With Complete Response (CR) to Treatment(Month 9 & Month 18)
- Number of Participants With Progressive Disease(PD) or Relapse From CR(Month 9 & Month 18)
Investigators
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