Multiple MyelomaPhase 3NCT00732641
Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)
A Phase 3 study testing Peginterferon in people with Multiple Myeloma, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Peginterferon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Nov 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
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)
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
- Being tested
- Peginterferon
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeginterferonDrug
Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Peginterferon |
| No Treatment | No intervention | Participants will be observed and will receive no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
CR was defined as:
- Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks;
- <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy was performed.
- No increase in size or number of lytic bone lesions (development of a compression fracture did not include response);
- Disappearance of soft tissue plasmocytomas.
Measured: Month 9 & Month 18
Number of Participants With Partial Response (PR) to Treatment
PR was defined as:
- At least 50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks;
- Reduction in 24-hour urinary light chain excretion either by ≥ 90% or to < 200 mg, maintained for a minimum of 6 weeks;
- For patients with non-secretory myeloma only, ≥ 50% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;
- At least 50% reduction in the size of soft tissue plasmacytomas;
- No increase in size or number of lytic bone lesions.
Measured: Month 9 & Month 18
Number of Participants With Minimal Response (MR) to Treatment
MR was defined as:
- A 25-49% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks;
- Reduction in the 24-hour urinary light chain excretion, which still exceeded 200mg/24 hours, maintained for a minimum of 6 weeks;
- For patients with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;
- A 25-49% reduction in the size of soft tissue plasmacytomas;
- No increase in the size or number of lityc lesions.
Measured: Month 9 & Month 18
Number of Participants With Progressive Disease(PD) or Relapse From CR
PD (for patients not in CR) required one or more of the following:
- 25% increase in serum monoclonal paraprotein level, 24-hour urinary light chain excretion, or plasma cells;
- Increase in size of existing or development of new bone lesions/soft tissue plasmacytomas;
- Development of hypercalcemia.
Relapse from CR required at least one of the following:
- Reappearance of serum or urinary paraprotein;
- >5% plasma cells;
- Development of new lytic bone lesions or soft tissue plasmacytomas or increase in the size of residual bone lesions;
- Development of hypercalcemia.
Measured: Month 9 & Month 18
Quality of Life
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).
Measured: Screening and Last Observation (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startDec 2000
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732641
- Sponsor's protocol ID
- P01972
- Status last verified
- Mar 2017
- First submitted
- 8 Aug 2008
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00732641
- Acronym / sponsor ID
- P01972
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 12 Aug 2008 (estimated)
- Results
- Posted 2 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peginterferon α-2b | Experimental | Drug: PeginterferonPeginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years. |
| No Treatment | No intervention | –Participants will be observed and will receive no treatment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- Is in a situation or condition that, in the opinion of the investigator, may interfere with optimal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeginterferonPeginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years. | Drug | Peginterferon α-2b |
Primary outcome
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.
6 secondary outcomes
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)
Number of Participants With Complete Response (CR) to Treatment
Time frame: Month 9 & Month 18
Number of Participants With Partial Response (PR) to Treatment
Time frame: Month 9 & Month 18
Number of Participants With Minimal Response (MR) to Treatment
Time frame: Month 9 & Month 18
Number of Participants With Progressive Disease(PD) or Relapse From CR
Time frame: Month 9 & Month 18
Quality of Life
Time frame: Screening and Last Observation (up to 5 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peginterferon in people with Multiple Myeloma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.