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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)


Phase 3
18 Years
85 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Days With Progression Free Survival (PFS)

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Authority:

Italy: Ministry of Health

Study ID:

P01972

NCT ID:

NCT00732641

Start Date:

December 2000

Completion Date:

November 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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