NCT00689936 · REGISTRY CONDITION SEARCH

Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2019-11-20

The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)

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outcome · POSTED

Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis

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outcome · POSTED

Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)

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outcome · POSTED

Percentage of Participants With an Objective Response Based on IRAC Review

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outcome · POSTED

Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis

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outcome · POSTED

Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC

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outcome · POSTED

Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis

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outcome · POSTED

Time to First Response Based on the Review by the IRAC

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outcome · POSTED

Time to First Response Based on the Investigator Assessment at the Time of Final Analysis

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outcome · POSTED

Kaplan Meier Estimates of Time to Treatment Failure (TTF)

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outcome · POSTED

Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis

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outcome · POSTED

Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)

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outcome · POSTED

Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis

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outcome · POSTED

Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis

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outcome · POSTED

Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.

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outcome · POSTED

Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review

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outcome · POSTED

Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review

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outcome · POSTED

Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review

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outcome · POSTED

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Fatigue Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Pain Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Insomnia Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Constipation Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain

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outcome · POSTED

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale

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outcome · POSTED

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale

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outcome · POSTED

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale

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outcome · POSTED

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale

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outcome · POSTED

Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score

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outcome · POSTED

Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year

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outcome · POSTED

Number of Participants With Adverse Events (AEs) During the Active Treatment Phase

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outcome · POSTED

Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase

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outcome · POSTED

Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase

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outcome · POSTED

Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase

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outcome · POSTED

Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.

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outcome · POSTED

Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Must understand and voluntarily sign informed consent form 2. Age ≥ 18 years at the time of signing consent 3. Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: * MM diagnostic criteria (all 3 required): * Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma * Monoclonal protein present in the serum and/or urine * Myeloma-related organ dysfunction (at least one of the following) \[C\] Calcium elevation in the blood (serum calcium \>10.5 mg/dl or upper limit of normal) \[R\] Renal insufficiency (serum creatinine \>2 mg/dl) \[A\] Anemia (hemoglobin \<10 g/dl or 2 g \< laboratory normal) \[B\] Lytic bone lesions or osteoporosis AND have measurable disease by protein electrophoresis analyses as defined by the following: * IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours * IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours * IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours * IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours * Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because: * The patient declines to undergo stem cell transplantation or * Stem cell transplantation is not available to the patient due to cost or other reasons 4. ECOG performance status of 0, 1, or 2 5. Able to adhere to the study visit schedule and other protocol requirements 6. Females of child-bearing potential (FCBP)\^2: 1. Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence. 2. Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy. 7. Male Patients: 1. Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy. 2. Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy. 3. Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy. 8. All patients must: 1. Have an understanding that the study drug could have a potential teratogenic risk. 2. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. 3. Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure. Exclusion Criteria: 1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \[i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization\]). 2. Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment. 3. Pregnant or lactating females. 4. Any of the following laboratory abnormalities: * Absolute neutrophil count (ANC) \< 1,000/µL (1.0 x 109/L) * Untransfused platelet count \< 50,000 cells/µL (50 x 10\^9/L) * Serum SGOT/AST or SGPT/ALT \> 3.0 x upper limit of normal (ULN) 5. Renal failure requiring hemodialysis or peritoneal dialysis. 6. Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following: * Basal cell carcinoma of the skin * Squamous cell carcinoma of the skin * Carcinoma in situ of the cervix * Carcinoma in situ of the breast * Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) 7. Patients who are unable or unwilling to undergo antithrombotic therapy. 8. Peripheral neuropathy of \> grade 2 severity. 9. Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis. * 1 A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related. * 2 A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Lenalidomide plus low-dose dexamethasone given until disease progression
intervention Names
Drug: Lenalidomide and low-dose dexamethasone
label
Lenalidomide / Dexamethasone until disease progression
type
EXPERIMENTAL
description
Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
intervention Names
Drug: Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
label
Lenalidomide / Dexamethasone for 18 cycles
type
EXPERIMENTAL
description
Combination of Melphalan, Prednisone and Thalidomide given for 12 six-week cycles
intervention Names
Drug: Melphalan, Prednisone and Thalidomide
label
Melphalan, Prednisone, and Thalidomide (MPT) for 12 cycles
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Lenalidomide / Dexamethasone until disease progression
description
Lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg 20mg, or 25 mg capsules, given either days 1-21 of each 28 day cycles or given every other day for 21 days until documentation of PD. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle up to disease progression
name
Lenalidomide and low-dose dexamethasone
other Names
Revlimid
type
DRUG
arm Group Labels
Lenalidomide / Dexamethasone for 18 cycles
description
lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg, 20 mg or 25 mg capsules given on days 1-21 of each 28 day cycle or every other day for 21 days for 18 cycles. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle for 18 cycles
name
Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
other Names
Revlimid
type
DRUG
arm Group Labels
Melphalan, Prednisone, and Thalidomide (MPT) for 12 cycles
description
Melphalan - oral, 2mg tablets dosed at either 0.25mg/kg, 0.125 mg/kg, 0.20mg/kg or 0.10mg/kg on days 1-4 of each 42 day cycle up to 12 cycles Prednisone - oral, 5mg, 10mg, 20 mg and 50 mg tablets dosed at 2mg/kg daily days 1-4 of each 42 day cycle for up to 12 cycles Thalidomide - oral, 50mg, 100mg and 200 mg capsules dosed at either 100mg or 200 mg daily on days 1-41 of each 42 day cycle for up to 12 cycles
name
Melphalan, Prednisone and Thalidomide
other Names
Prednisone
Thalomid
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 1623
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).
measure
Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)
time Frame
From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.
description
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).
measure
Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis
time Frame
From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months

secondary Outcomes

description
Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive.
measure
Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)
time Frame
From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months
description
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
measure
Percentage of Participants With an Objective Response Based on IRAC Review
time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
description
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
measure
Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis
time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
description
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.
measure
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC
time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months
description
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.
measure
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis
time Frame
Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months
description
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria.
measure
Time to First Response Based on the Review by the IRAC
time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
description
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator.
measure
Time to First Response Based on the Investigator Assessment at the Time of Final Analysis
time Frame
Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
description
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.
measure
Kaplan Meier Estimates of Time to Treatment Failure (TTF)
time Frame
From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.
description
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.
measure
Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis
time Frame
From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.
description
Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy.
measure
Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)
time Frame
From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months
description
Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.
measure
Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis
time Frame
From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months
description
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
measure
Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis
time Frame
Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

Full study description

brief Summary: The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.
detailed Description: CC-5013-MM020/IFM 07-01 is a Phase III, multicenter, randomized, open-label, 3-arm study that will compare the efficacy and safety of two Lenalidomide plus low-dose dexamethasone regimens given for two different durations of time (i.e., until progressive disease \[PD\] or for up to a maximum of 18 four-week cycles) to that of MPT given for a maximum of 12 six-week cycles.

Source references

references

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