Mantle Cell Lymphoma
Conditions
Keywords
Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma, CC-5013, Revlimid, Lenalidomide
Brief summary
To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.
Detailed description
Follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first. All other efficacy and safety endpoints will be updated at this time. In the unlikely event that the study will be closed and patients are still responding to treatment at this time, Celgene will discuss with the treating physicians options to provide further treatment to the patient after study closure in line with local regulation. Follow up for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first. 10 October 2017: In regard to the last subject last visit date/study completion date, the prolongation of timelines is due to the bridging of a treatment gap for a patient responding to study medication until non-study medication is available.
Interventions
DRUGlenalidomide
25mg oral capsules continuous days 1-21 each of a 28 day cycle
Sponsors
Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy proven mantle cell lymphoma * Patients must have documents relapsed, refractory or PD after treatment with bortezomib * Must have measureable disease on cross sectional imaging by CT * Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2 * Willing to follow pregnancy precautions
Exclusion criteria
* Any of the following laboratory abnormalities * Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L) * Platelet count \< 60,000/mm3 (60 x 109/L) * Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) \> 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma. * Serum total bilirubin \> 1.5 x ULN, except in cases of Gilbert's Syndrome and documented liver involvement by lymphoma. * Calculated creatinine clearance (Cockcroft-Gault formula) of \< 30 mL /min * Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible * History of active central nervous system (CNS) lymphoma within the previous 3 months * Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis * Prior history of malignancies, other than MCL, unless the patient has been free of the disease for ≥ 3 years * Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC) | From Day 1 of study treatment to progession or early treatment discontinuation; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days. | Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed, or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. |
| Kaplan Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee | From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days. | Kaplan Meier estimate for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier Estimate of Progression-Free Survival (PFS) According to the Independent Review Committee | From Day 1 of study drug to first documented date of disease progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months | Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment. |
| Kaplan Meier Estimate of Time to Progression (TTP) According to the Independent Review Committee | From Day 1 of study drug to first documented time of progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months | Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir |
| Kaplan-Meier Estimate of Time to Treatment Failure (TTF) According to the Independent Review Committee | From Day 1 of study drug to first documented time of treatment failure; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days | Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data. |
| Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) According to the Independent Review Committee | From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days | The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other anti-lymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow. |
| Time to Complete Response (CR+CRu) According to the Independent Review Committee | From Day 1 of study drug to first documented CR/CRu or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days | Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu. |
| Overall Survival (OS) | From Day 1 of study drug to first documented date of progressive disease or death; up to the final data cut-off date of 30 March 2017; median duration of follow-up for surviving participants was 62.94 months | Kaplan Meier estimate of overall survival was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From the first dose of lenalidomide through 28 days after the last dose during the follow-up phase; median (minimum, maximum) duration of treatment was 94.0 (1.0, 1950 days) | Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. |
| Time to Response (TTR) | From Day 1 of study drug to time of first documented PR or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days | Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants. |
| Kaplan Meier Estimate of Duration of Complete Response (DoCR) (CR+CRu) According to the Independent Review Committee | From Day 1 of study drug to progression or early discontinuation; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months | Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment. |
Countries
Austria, Belgium, Colombia, France, Germany, Hungary, Israel, Italy, Puerto Rico, Singapore, Spain, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled and treated at 42 centers in 12 countries: US/ Puerto Rico, France, Israel, Belgium, Spain, Turkey, Austria, Hungary, Italy, Colombia, Germany, and Singapore.
Pre-assignment details
All participants were required to have local histologic confirmation of Mantle Cell Lymphoma (MCL) for entry into the study.
Participants by arm
| Arm | Count |
|---|---|
| Lenalidomide Participants received lenalidomide 10 mg or 25 mg oral capsules on days 1 to 21 of each 28-day cycle and was dependent on renal function; Participants with normal renal function (defined as creatinine clearance (CrCl)) of ≥ 60 mL/min) received 25 mg of lenalidomide by mouth (PO) daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but \< 60 mL/min) were started at a 10 mg daily dose. Participants could continue to receive treatment until disease progression, development of unacceptable adverse events (AEs), or voluntary withdrawal. | 134 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 24 |
| Overall Study | Death | 4 |
| Overall Study | Disease Progression | 95 |
| Overall Study | Other | 4 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Lenalidomide |
|---|---|
| Age, Continuous | 67.2 Years STANDARD_DEVIATION 8.38 |
| Age, Customized <65 | 49 Participants |
| Age, Customized ≥ 65 | 85 Participants |
| Bulky Disease Missing | 2 Participants |
| Bulky Disease No | 88 Participants |
| Bulky Disease Yes | 44 Participants |
| Duration of Mantle Cell Lymphoma <3 years | 52 years |
| Duration of Mantle Cell Lymphoma ≥ 3 years | 82 years |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 = (Fully Active) | 43 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 = (Restrictive but ambulatory) | 73 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 = (Ambulatory but unable to work) | 17 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 3 = (Limited self care) | 1 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 4 = (Completely Disabled) | 0 Participants |
| MCL (Ann Arbor) Stage at Diagnosis I | 2 Participants |
| MCL (Ann Arbor) Stage at Diagnosis II | 5 Participants |
| MCL (Ann Arbor) Stage at Diagnosis III | 19 Participants |
| MCL (Ann Arbor) Stage at Diagnosis IV | 105 Participants |
| MCL (Ann Arbor) Stage at Diagnosis Missing | 3 Participants |
| MCL International Prognostic Index (MIPI) Score Group at Enrollment High | 39 Participants |
| MCL International Prognostic Index (MIPI) Score Group at Enrollment Intermediate | 51 Participants |
| MCL International Prognostic Index (MIPI) Score Group at Enrollment Low | 39 Participants |
| MCL International Prognostic Index (MIPI) Score Group at Enrollment Missing | 5 Participants |
| Prior Bone Marrow Assessment Indeterminate | 8 Participants |
| Prior Bone Marrow Assessment Missing | 19 Participants |
| Prior Bone Marrow Assessment Negative | 52 Participants |
| Prior Bone Marrow Assessment Positive | 55 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White or Caucasian | 128 Participants |
| Renal function at baseline Missing | 6 Participants |
| Renal function at baseline Moderate Renal Insufficiency (CrCl ≥ 30 and < 60mL | 28 Participants |
| Renal function at baseline Normal (CrCl > = 60 mL/min) | 99 Participants |
| Renal function at baseline Severe Renal Insufficiency (CrCl < 30 mL/min) | 1 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 108 Participants |
| Tumor Burden High = having 1 lesion ≥ 5 cm or 3 lesions ≥ 3cm | 78 Participants |
| Tumor Burden Low = < 5cm lesions | 54 Participants |
| Tumor Burden Missing = unable to characterize | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 106 / 134 |
| other Total, other adverse events | 125 / 134 |
| serious Total, serious adverse events | 70 / 134 |
Outcome results
Primary
Kaplan Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee
Kaplan Meier estimate for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment.
Time frame: From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days.
Population: Includes participants from the ITT population who achieved a PR or better.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide | Kaplan Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee | 16.64 months |
Primary
Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC)
Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed, or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses.
Time frame: From Day 1 of study treatment to progession or early treatment discontinuation; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days.
Population: ITT population defined as all enrolled participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide | Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC) | 29.9 percentage of participants |
Secondary
Kaplan Meier Estimate of Duration of Complete Response (DoCR) (CR+CRu) According to the Independent Review Committee
Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment.
Time frame: From Day 1 of study drug to progression or early discontinuation; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Population: Includes participants from the ITT population who achieved a CRu or better.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide | Kaplan Meier Estimate of Duration of Complete Response (DoCR) (CR+CRu) According to the Independent Review Committee | 24.43 months |
Secondary
Kaplan-Meier Estimate of Progression-Free Survival (PFS) According to the Independent Review Committee
Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.
Time frame: From Day 1 of study drug to first documented date of disease progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Population: Intent to Treat population defined as all enrolled participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide | Kaplan-Meier Estimate of Progression-Free Survival (PFS) According to the Independent Review Committee | 4.01 months |
Secondary
Kaplan Meier Estimate of Time to Progression (TTP) According to the Independent Review Committee
Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir
Time frame: From Day 1 of study drug to first documented time of progression; up to data cut-off date of 06 April 2016; median time in follow-up was 16.34 months
Population: Intent to Treat population was defined as all enrolled participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide | Kaplan Meier Estimate of Time to Progression (TTP) According to the Independent Review Committee | 5.46 months |
Secondary
Kaplan-Meier Estimate of Time to Treatment Failure (TTF) According to the Independent Review Committee
Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data.
Time frame: From Day 1 of study drug to first documented time of treatment failure; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Population: Intent to Treat population was defined as all enrolled participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide | Kaplan-Meier Estimate of Time to Treatment Failure (TTF) According to the Independent Review Committee | 3.75 months |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.
Time frame: From the first dose of lenalidomide through 28 days after the last dose during the follow-up phase; median (minimum, maximum) duration of treatment was 94.0 (1.0, 1950 days)
Population: The safety population received at least one dose of lenalidomide was used for all safety analysis. This was identical to the ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE | 132 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE Related to Investigational Product (IP) | 118 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE Grade 3-5 AE | 106 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE Grade 3 AE | 101 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE Grade 4 AE | 57 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE Grade 5 AE | 18 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3-5 AE Related to IP | 90 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 3 AE Related to IP | 88 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 4 AE Related to IP | 41 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Grade 5 AE Related to IP | 2 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE Serious Adverse Event (SAE) | 70 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any SAE Related to IP | 30 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any TEAE Leading to Stopping of IP | 28 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Treatment Related AE Leading to Stopping IP | 16 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any AE Leading to Dose Reduction | 55 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any AE Leading to IP Interruption | 81 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Any Treatment Related AE Leading to Dose Reduction | 52 participants |
| Lenalidomide | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment Related AE Leading to IP Interruption | 66 participants |
Secondary
Overall Survival (OS)
Kaplan Meier estimate of overall survival was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive.
Time frame: From Day 1 of study drug to first documented date of progressive disease or death; up to the final data cut-off date of 30 March 2017; median duration of follow-up for surviving participants was 62.94 months
Population: Intent to Treat population defined as all enrolled participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide | Overall Survival (OS) | 19.50 months |
Secondary
Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) According to the Independent Review Committee
The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other anti-lymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow.
Time frame: From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days
Population: The ITT population was defined as all enrolled participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide | Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) According to the Independent Review Committee | 9.0 percentage of participants |
Secondary
Time to Complete Response (CR+CRu) According to the Independent Review Committee
Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu.
Time frame: From Day 1 of study drug to first documented CR/CRu or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Population: Included participants from the ITT population who achieved a CRu or better.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide | Time to Complete Response (CR+CRu) According to the Independent Review Committee | 3.9 months |
Secondary
Time to Response (TTR)
Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants.
Time frame: From Day 1 of study drug to time of first documented PR or better; up to data cut-off date of 06 April 2016; median duration of treatment was 94.5 days
Population: Included participants from the ITT population who achieved a PR or better.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide | Time to Response (TTR) | 3.5 months |