Acute Myelogenous Leukemia, Acute Myeloid Leukemia
Conditions
Keywords
AML, elderly, acute myelogenous leukemia, vidaza, azacitidine, elderly AML, revlimid, lenalidomide
Brief summary
The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).
Detailed description
On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns. The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the lenalidomide only arm.
Interventions
DRUGAzacitidine
Azacitidine at 75 mg/m\^2/day subcutaneous on Days 1-7
DRUGLenalidomide
Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily
OTHERBest Supportive Care (BSC)
The use of BSC was considered as concomitant treatment and must be documented as concomitant medication. BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML * Male or female subjects aged ≥ 65 * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * White blood cell (WBC) count ≤ 10 x 10⁹/L at screening
Exclusion criteria
* Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide * Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents. * Suspected or proven acute promyelocytic leukemia * Prior bone marrow or stem cell transplantation * Candidate for allogeneic bone marrow or stem cell transplantation * AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms * Presence of malignant disease within the previous 12 months with exceptions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months) | Overall Survival reported at the end of the study are for those participants who were alive at the end of the study |
| Kaplan Meier Estimates for One Year Survival | Up to 24 months | One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Remission (DoR) | Duration of Remission (DoR) time frame not analyzed. | Duration of remission was defined as the time from the date of CR or CRi until relapse. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed. |
| Cytogenetic Complete Remission Rate (CRc) | Cytogenetic Complete Remission timeframe was not analyzed. | The CRc response category is comprised of the subset of participants who had abnormal cytogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed. |
| Percentage of Participants With an Overall Response Rate (CR +CRi+ PR) | Overall response rate time frame was not analyzed. | Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with auer rods) and ANC of ≥ 1 x 10\^9/L, a platelet count ≥ 100 x 10\^9/L, no transfusions for 1 week prior to each assessment. No duration of these findings is required for confirmation of this response. Morphologic complete remission with incomplete blood count recovery was defined as a morphologic complete remission but the ANC may be \< 1 x 10\^9/L and/or the platelet count may be \< 100 x 10\^9/L. Partial remission was defined as an ANC \> 1 x 10\^9/L and platelet count ≥ 100 x 10\^9/L with a \> 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if auer rods are present). Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed. |
| Progression-Free Survival (PFS) | Progression-Free survival data and time frame was not analyzed. | PFS is defined as the time from randomization to the first observation of documented disease progression or death from any cause whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed. |
| Relapse-Free Survival (RFS) | Relapse-Free survival time frame was not analyzed. | RFS is defined only for subjects that achieve CR and CRi and is measured as the interval from that date to the date of disease relapse, death from any cause, whichever occurs first, censoring at the last visit date for subjects alive in continuous CR/CRi. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed. |
| Percentage of Participants With 30-Day Treatment-Related Mortality | 30 days | 30-day mortality rate was defined as death from any cause within 30 days after first dose. |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018 | TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death |
| Number of Participants With a Second Primary Malignancy | From randomization of the last participant up to a minimum of 4 years following discontinuation | Second primary malignancies were monitored as events of interest and reported as serious adverse events regardless of the treatment arm the participant was enrolled in. |
| Event-Free Survival (EFS) | Event-Free survival time was not analyzed. | EFS was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed. |
| Percentage of Participants With a Complete Response or Morphologic Incomplete Response. | Complete Response or Morphologic Incomplete Response data not analyzed. | Based on IWG response criteria for AML. Complete remission (CR), morphologic complete remission (CR) was defined as \< 5% bone marrow blasts, an absolute neutrophil count ≥ 1 x 10\^9/L, platelets ≥100 x 10\^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. Morphologic CR with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC count may be \<1 x 10\^9/L and/or the platelet count may be \<100 x 10\^9/L. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Alive at One Year | Up to 12 months | Defined as the percentage of participants who survived at one year |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were randomized at 25 sites in North America (Canada and the United States).
Pre-assignment details
Participants were centrally randomized 1:1:1 and stratified by the Eastern Cooperative Oncology Group (ECOG) performance score (0 to 1 versus 2) and peripheral blood blast count (\<1 versus ≥ 1 x 10\^9/L).
Participants by arm
| Arm | Count |
|---|---|
| Lenalidomide Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion. | 15 |
| Azacitidine + Lenalidomide Participants received azacitidine 75 mg/m\^2/ daily SC on Days 1 through 7 and lenalidomide 50 mg daily PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care | 39 |
| Azacitidine Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC | 34 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 7 | 3 |
| Overall Study | Death | 3 | 7 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 | 3 |
| Overall Study | Non-compliance with study drug | 0 | 0 | 1 |
| Overall Study | Other | 2 | 5 | 4 |
| Overall Study | Progressive Disease | 5 | 13 | 16 |
| Overall Study | Protocol Violation | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 6 | 3 |
Baseline characteristics
| Characteristic | Lenalidomide | Azacitidine + Lenalidomide | Azacitidine | Total |
|---|---|---|---|---|
| Age, Continuous | 77.6 years STANDARD_DEVIATION 5.47 | 75.5 years STANDARD_DEVIATION 5.88 | 74.8 years STANDARD_DEVIATION 4.96 | 75.97 years STANDARD_DEVIATION 5.44 |
| Eastern Cooperative Oncology Group Performance Status 0 = (Fully Active) | 4 Participants | 4 Participants | 10 Participants | 18 Participants |
| Eastern Cooperative Oncology Group Performance Status 1 = (Restrictive but ambulatory) | 9 Participants | 28 Participants | 17 Participants | 54 Participants |
| Eastern Cooperative Oncology Group Performance Status 3 = (Limited self care) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Eastern Cooperative Oncology Group Performance Status 4 = (Completely Disabled) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Eastern Cooperative Oncology Group Performance Status (Ambulatory but unable to work) | 2 Participants | 7 Participants | 6 Participants | 15 Participants |
| Eastern Cooperative Oncology Group Performance Status Missing | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Peripheral Blast Blood Count <1 X 10^9L | 11 Participants | 31 Participants | 27 Participants | 69 Participants |
| Peripheral Blast Blood Count ≥1 X 10^9L | 4 Participants | 8 Participants | 7 Participants | 19 Participants |
| Sex: Female, Male Female | 3 Participants | 17 Participants | 15 Participants | 35 Participants |
| Sex: Female, Male Male | 12 Participants | 22 Participants | 19 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 14 | 34 / 38 | 29 / 32 |
| other Total, other adverse events | 14 / 14 | 38 / 38 | 32 / 32 |
| serious Total, serious adverse events | 13 / 14 | 29 / 38 | 25 / 32 |
Outcome results
Primary
Kaplan Meier Estimates for One Year Survival
One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation
Time frame: Up to 24 months
Population: ITT included all randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide | Kaplan Meier Estimates for One Year Survival | 3.00 months |
| Azacitidine Plus Lenalidomide | Kaplan Meier Estimates for One Year Survival | 9.61 months |
| Azacitidine | Kaplan Meier Estimates for One Year Survival | 13.67 months |
p-value: 0.11995% CI: [0.861, 3.718]Log Rank
p-value: 0.01495% CI: [1.214, 5.822]Log Rank
p-value: 0.35695% CI: [0.704, 2.653]Log Rank
Primary
Overall Survival
Overall Survival reported at the end of the study are for those participants who were alive at the end of the study
Time frame: From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)
Population: Participants who were still alive at the end of the study and in safety population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide | Overall Survival | 0.2 months |
| Azacitidine Plus Lenalidomide | Overall Survival | 7.1 months |
| Azacitidine | Overall Survival | 4.1 months |
Secondary
Cytogenetic Complete Remission Rate (CRc)
The CRc response category is comprised of the subset of participants who had abnormal cytogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time frame: Cytogenetic Complete Remission timeframe was not analyzed.
Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Secondary
Duration of Remission (DoR)
Duration of remission was defined as the time from the date of CR or CRi until relapse. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time frame: Duration of Remission (DoR) time frame not analyzed.
Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Secondary
Event-Free Survival (EFS)
EFS was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time frame: Event-Free survival time was not analyzed.
Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Secondary
Number of Participants With a Second Primary Malignancy
Second primary malignancies were monitored as events of interest and reported as serious adverse events regardless of the treatment arm the participant was enrolled in.
Time frame: From randomization of the last participant up to a minimum of 4 years following discontinuation
Population: Safety population includes all participants who received at least one dose of IP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide | Number of Participants With a Second Primary Malignancy | 0 Participants |
| Azacitidine Plus Lenalidomide | Number of Participants With a Second Primary Malignancy | 0 Participants |
| Azacitidine | Number of Participants With a Second Primary Malignancy | 3 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAE)
TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
Time frame: From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018
Population: Safety population includes all participants who have received at least 1 dose of Investigational Product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1TEAE leading to dose reduction of study drug | 0 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1TEAE leading to dose interruption of study drug | 8 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE CTCAE Grade 3 or 4 TEAE | 14 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any TEAE | 14 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE related to study drug | 13 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE CTCAE Gr 3 or 4 TEAE related to study drug | 11 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE CTCAE Grade 5 | 5 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 Serious TEAE | 13 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 Serious TEAE related to study drug | 10 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1TEAE leading to discontinuation of study drug | 6 participants |
| Azacitidine Plus Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1TEAE leading to discontinuation of study drug | 12 participants |
| Azacitidine Plus Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any TEAE | 38 participants |
| Azacitidine Plus Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 Serious TEAE related to study drug | 16 participants |
| Azacitidine Plus Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE CTCAE Gr 3 or 4 TEAE related to study drug | 25 participants |
| Azacitidine Plus Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE CTCAE Grade 5 | 10 participants |
| Azacitidine Plus Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 Serious TEAE | 29 participants |
| Azacitidine Plus Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1TEAE leading to dose reduction of study drug | 8 participants |
| Azacitidine Plus Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1TEAE leading to dose interruption of study drug | 21 participants |
| Azacitidine Plus Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE related to study drug | 35 participants |
| Azacitidine Plus Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE CTCAE Grade 3 or 4 TEAE | 34 participants |
| Azacitidine | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE CTCAE Grade 5 | 5 participants |
| Azacitidine | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE CTCAE Grade 3 or 4 TEAE | 29 participants |
| Azacitidine | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1TEAE leading to discontinuation of study drug | 4 participants |
| Azacitidine | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE related to study drug | 30 participants |
| Azacitidine | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Any TEAE | 32 participants |
| Azacitidine | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1TEAE leading to dose interruption of study drug | 10 participants |
| Azacitidine | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 Serious TEAE related to study drug | 7 participants |
| Azacitidine | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 TEAE CTCAE Gr 3 or 4 TEAE related to study drug | 18 participants |
| Azacitidine | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1 Serious TEAE | 25 participants |
| Azacitidine | Number of Participants With Treatment Emergent Adverse Events (TEAE) | ≥1TEAE leading to dose reduction of study drug | 2 participants |
Secondary
Percentage of Participants With 30-Day Treatment-Related Mortality
30-day mortality rate was defined as death from any cause within 30 days after first dose.
Time frame: 30 days
Population: ITT included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide | Percentage of Participants With 30-Day Treatment-Related Mortality | 13.3 percentage of participants |
| Azacitidine Plus Lenalidomide | Percentage of Participants With 30-Day Treatment-Related Mortality | 17.9 percentage of participants |
| Azacitidine | Percentage of Participants With 30-Day Treatment-Related Mortality | 5.9 percentage of participants |
Secondary
Percentage of Participants With a Complete Response or Morphologic Incomplete Response.
Based on IWG response criteria for AML. Complete remission (CR), morphologic complete remission (CR) was defined as \< 5% bone marrow blasts, an absolute neutrophil count ≥ 1 x 10\^9/L, platelets ≥100 x 10\^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. Morphologic CR with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC count may be \<1 x 10\^9/L and/or the platelet count may be \<100 x 10\^9/L. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time frame: Complete Response or Morphologic Incomplete Response data not analyzed.
Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Secondary
Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)
Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with auer rods) and ANC of ≥ 1 x 10\^9/L, a platelet count ≥ 100 x 10\^9/L, no transfusions for 1 week prior to each assessment. No duration of these findings is required for confirmation of this response. Morphologic complete remission with incomplete blood count recovery was defined as a morphologic complete remission but the ANC may be \< 1 x 10\^9/L and/or the platelet count may be \< 100 x 10\^9/L. Partial remission was defined as an ANC \> 1 x 10\^9/L and platelet count ≥ 100 x 10\^9/L with a \> 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if auer rods are present). Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time frame: Overall response rate time frame was not analyzed.
Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Secondary
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first observation of documented disease progression or death from any cause whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time frame: Progression-Free survival data and time frame was not analyzed.
Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Secondary
Relapse-Free Survival (RFS)
RFS is defined only for subjects that achieve CR and CRi and is measured as the interval from that date to the date of disease relapse, death from any cause, whichever occurs first, censoring at the last visit date for subjects alive in continuous CR/CRi. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Time frame: Relapse-Free survival time frame was not analyzed.
Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Other Pre-specified
Percentage of Participants Alive at One Year
Defined as the percentage of participants who survived at one year
Time frame: Up to 12 months
Population: ITT population included participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide | Percentage of Participants Alive at One Year | 21.4 Percentage of participants |
| Azacitidine Plus Lenalidomide | Percentage of Participants Alive at One Year | 43.9 Percentage of participants |
| Azacitidine | Percentage of Participants Alive at One Year | 52.3 Percentage of participants |