Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)

NCT00732641 | Completed Phase 3 Results DMC

• 1 other identifier: P01972
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• 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 Complete Response (CR) to Treatment

  Month 9 & Month 18

• Number of Participants With Partial Response (PR) to Treatment

  Month 9 & Month 18

• Number of Participants With Minimal Response (MR) to Treatment

  Month 9 & Month 18

• Number of Participants With Progressive Disease(PD) or Relapse From CR

  Month 9 & Month 18

Study Arms (2)

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

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 12, 2008
• Study Start: December 1, 2000
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 4, 2017
• Results First Posted: December 2, 2011

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share