Peginterferon α-2b as a Maintenance Therapy in Participan... | NCT00732641

NCT00732641

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Peginterferon
No Treatment	No Intervention	Participants will be observed and will receive no treatment.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peginterferon	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Days With Progression Free Survival (PFS)	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 Outcomes

Measure	Description	Time Frame
Number of Days of Overall Survival (OS)	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)

Eligibility Module

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

Contacts/Locations Module

No data available

No data is available for this block.

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	No Treatment	Participants were observed and received no treatment

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000123 subjects FG001121 subjects
COMPLETED		FG00017 subjects FG0019 subjects
NOT COMPLETED		FG000106 subjects FG001112 subjects

Type	Comment	Reasons
Relapse or Progressive Disease		FG00065 subjects FG001101 subjects
Serious Adverse Events		FG00012 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	No Treatment	Participants were observed and received no treatment

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous	Age was for the intent-to-treat population (those who received at least one dose of study drug)

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Days With Progression Free Survival (PFS)

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.

Intent-to-treat population (those who received at least one dose of study drug)

Posted

Median

95% Confidence Interval

Days

Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)

ID	Title	Description
OG000	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.
OG001

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Senior Vice President, Global Clinical Development	Merck Sharp & Dohme Corp.			ClinicalTrialsDisclosure@merck.com

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D009101	Multiple Myeloma

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

EG0001 events1 affected123 at risk

EG0011 events1 affected121 at risk

EG00013 events13 affected123 at risk

EG00117 events15 affected121 at risk