- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00732641
Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peginterferon α-2b
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
|
No Intervention: No Treatment
Participants will be observed and will receive no treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Days of Overall Survival (OS)
Time Frame: Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)
|
OS was calculated from the date of randomization to the date of death for any cause. Participants alive at the end of study were censored at the last date they were known to be alive. Participants who were still living at the end of the study were censored on the last date they were known to be alive. |
Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)
|
Number of Participants With Complete Response (CR) to Treatment
Time Frame: Month 9 & Month 18
|
CR was defined as:
|
Month 9 & Month 18
|
Number of Participants With Partial Response (PR) to Treatment
Time Frame: Month 9 & Month 18
|
PR was defined as:
|
Month 9 & Month 18
|
Number of Participants With Minimal Response (MR) to Treatment
Time Frame: Month 9 & Month 18
|
MR was defined as:
|
Month 9 & Month 18
|
Number of Participants With Progressive Disease(PD) or Relapse From CR
Time Frame: Month 9 & Month 18
|
PD (for patients not in CR) required one or more of the following:
Relapse from CR required at least one of the following:
|
Month 9 & Month 18
|
Quality of Life
Time Frame: Screening and Last Observation (up to 5 years)
|
Participants were given the Europen Organization for Research in Cancer Therapy Quality of Life Questionnaire (EORTC QLQ), version 2.0, which consisted of 30 questions.
The questionnaire evaluated global health/quality of life and incorporated five functional scales (Physical; Role; Emotional; Cognitive; Social).
All of the scales ranged in score from 0 (worst) to 100 (best).
|
Screening and Last Observation (up to 5 years)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- P01972
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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