Clinical trial NCT00732641: Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-12
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Days With Progression Free Survival (PFS)
timeFrame: Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)
Secondary outcomes:
measure: Number of Days of Overall Survival (OS)
timeFrame: Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)
measure: Number of Participants With Complete Response (CR) to Treatment
timeFrame: Month 9 & Month 18
measure: Number of Participants With Partial Response (PR) to Treatment
timeFrame: Month 9 & Month 18
measure: Number of Participants With Minimal Response (MR) to Treatment
timeFrame: Month 9 & Month 18
measure: Number of Participants With Progressive Disease(PD) or Relapse From CR
timeFrame: Month 9 & Month 18
measure: Quality of Life
timeFrame: Screening and Last Observation (up to 5 years)
Other outcomes:
Locations:
Study officials:
References: