Newly Diagnosed Multiple Myeloma
Conditions
Keywords
Newly Diagnosed Multiple Myeloma, Celgene, CC-5013, Revlimid, Lenalidomide, Melphalan, Prednisone, Elderly
Brief summary
The purpose of this study is to determine whether lenalidomide is safe and effective in the treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older.
Detailed description
The three phases for the study as originally defined and as represented in the results of 11 May 2010 are: Double-blind Treatment Phase: Induction Melphalan/prednisone and lenalidomide 10 mg (MPR) (2 treatment arms), or melphalan/prednisone and placebo (MPp) (1 treatment arm) for up to 9 cycles. If disease progression, subjects have the option to enter into the Open-Label Extension Phase. There is also an option to enter into the Follow-Up Phase. If the disease has not progressed, subject can continue on blinded therapy into Maintenance. Double-blind Treatment Phase: Maintenance One MPR treatment arm (MPR+R) will continue taking lenalidomide 10 mg in Maintenance. The other MPR treatment arm (MPR+p) will take placebo in Maintenance. The MP p treatment arm will take placebo in Maintenance (MPp+p). If disease progression, subjects have the option to enter the Open-Label Extension Phase to obtain treatment with lenalidomide, or to enter into the Follow-up Phase. Open-label Extension Phase: Treatment consists of oral lenalidomide (up to 25 mg) with or without dexamethasone until disease progression or treatment is discontinued for any reason until all study subjects are followed for at least 5 years from the date of randomization or have died. Subjects who discontinue from the Open-Label Extension Phase prior to completing a total of 5 years in the study will enter the Follow-up Phase. Follow-up Phase: Subjects are followed for overall survival and subsequent anti-myeloma treatment regimens until all subjects in this study are followed for at least 5 years from randomization or have died. The pre-planned interim analysis for the Independent Data Monitoring Committee (IDMC) showed that the difference in progression-free survival (PFS) between treatment arms MPR+R and MPp+p (the defined primary comparative analysis for this study) surpassed the pre-specified O'Brien-Fleming boundary for superiority. The IDMC recommended the release of this information to the sponsor and also recommended that all patient and physician study participants receive information concerning the full findings of the MM-015 interim analysis. Therefore, due to these recommendations from the IDMC, treatment-arm codes were sent to the clinical trial centers to unblind the treatment arms of their study subjects once the amended protocol was reviewed and approved by the respective country Health Authorities and Ethics Committees. Subject participation in the MM-015 study continued after unblinding to obtain long-term data for all study endpoints, including overall survival. When the study was unblinded, subjects still on protocol therapy had completed the Double-Blind Induction, and were on monotherapy in Double-Blind Maintenance. Subjects in arm MPR+R continued their monotherapy on lenalidomide. Subjects in arms MPR+p and MPp+p discontinued their placebo monotherapy and went into an observation period in which no antimyeloma therapy was taken. If disease progressed for any subject, the investigator had the option of entering the subject in Open Label Extension Phase to receive lenalidomide therapy (up to 25 mg daily) or the Follow-up Phase. All subjects were to be followed for at least 5 years from the start of the study.
Interventions
DRUGLenalidomide: Double-blind Induction
Double-blind Induction: the starting lenalidomide oral dosing regimen was 10 mg once daily on Days 1 through 21 of each 28 day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
DRUGMelphalan
Double-blind Induction: the starting melphalan oral dosing regimen in all 3 treatment arms was 0.18 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
DRUGPrednisone
Double-blind induction: the starting prednisone oral dosing regimen in all 3 treatment arms was 2 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.
DRUGAspirin
Double-blind induction: low-dose aspirin 75 mg to 100 mg daily for all treatment arms. Double-blind maintenance: at the investigator's discretion
DRUGPlacebo
Double-blind induction: participants in treatment arm MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle for up to 9 cycles. Double-blind maintenance: participants in treatment arms MPR+p and MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.
DRUGLenalidomide: Double-blind Maintenance
Single-agent oral lenalidomide 10 mg once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.
DRUGLenalidomide: Open-label
Any study participant who had progressive disease had the option of open-label lenalidomide up to 25 mg daily on Days 1 through 21 of each 28-day cycle.
Sponsors
Celgene Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must understand and voluntarily sign an informed consent form 2. Age greater than or equal to 65 years at the time of signing the informed consent 3. Newly diagnosed with symptomatic multiple myeloma as defined by the 3 criteria below: MM diagnostic criteria (all of next 3 required) 1. Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma 2. Monoclonal protein present in the serum and/or urine 3. Myeloma-related organ dysfunction (at least one of the following) \[C\] Calcium elevation in the blood (serum calcium \>10.5mg/dl or upper limit of normal) \[R\] Renal insufficiency (serum creatinine \>2mg/dl) \[A\] Anemia (hemoglobin \<10g/dl or 2g \< normal) \[B\] Lytic bone lesions or osteoporosis AND have measurable disease as defined by the following; IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgA multiple myeloma: Serum M-protein level greater than or equal to 0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgD multiple myeloma: Serum M-protein level greater than or equal to 0.05 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours Light chain multiple myeloma: Serum M-protein level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level greater than or equal to 1.0g/dL or urine M-protein level greater than or equal to 200mg/24hours 4. Karnofsky performance status greater than or equal to 60%. 5. Able to adhere to the study visit schedule and other protocol requirements. 6. Women of Childbearing potential (WCBP) must: a. Have a negative medically supervised pregnancy test prior to the start of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices and continues sexual abstinence. b Either commit to 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 dose interruptions), and for 28 days after discontinuation of study therapy. 7. Males Subjects must: 1. Agree to use a condom during sexual contact with a WCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after the cessation of study therapy. 2. Agree to not donate semen during study drug therapy and for a period after end of study drug therapy. 8. All subjects must 1. Have an understanding that the study drug could have 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. 4. All patients must be counseled about pregnancy precautions and risks of fetal exposure. Female Subjects: Females of childbearing potential (FCBP) with regular cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following discontinuation from the study. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following discontinuation from the study. In addition to the required pregnancy testing, the Investigator must confirm with FCBP that she is continuing to use two reliable methods of birth control at each visit. Counseling about pregnancy precautions and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood. Pregnancy testing and counseling must be performed if a subject misses her period or if her pregnancy test or her menstrual bleeding is abnormal. Study drug treatment must be discontinued during this evaluation. Females must agree to abstain from breastfeeding during study participation and for at least 28 days after the discontinuation from the study. Male Subjects: Counseling about the requirement for latex condom use during sexual contact with females of childbearing potential and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood, sperm, or semen. If pregnancy or a positive pregnancy test does occur in a study subject or the partner of a study subject during study participation, study drug must be immediately discontinued.
Exclusion criteria
1. Previous treatment with antimyeloma 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 28 days \[4 weeks\] of randomization\]). 2. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds experimental the ability to interpret data from the study. 3. Pregnant or lactating females. 4. Radiotherapy within 14 days (2 weeks) of randomization. 5. Plasmapheresis within 28 days (4 weeks) of randomization. 6. Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) \< 1,500 cells/mL (1.5\*10\^9/L) Platelet count \< 75,000 cells/uL (75\*10\^9/L) for subjects in whom \< 50% of bone marrow nucleated cells are plasma cells; but platelet count \<30,000/uL for subjects in whom \>= 50% of bone marrow nucleated cells are plasma cells Haemoglobin \< 8.0 g/dL (80 g/L) Serum creatinine \> 2.5 mg/dL (221 µmol/L) Serum aspartate aminotransferase (SGOT/AST) or alanine aminotransferase (SGPT/ALT) \> 3.0 times upper limit of normal (ULN) 7. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for greater than or equal to 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 histologic finding of prostate cancer (TNM Classification of Malignant Tumours (TNM) stage of T1a or T1b) 8. Neuropathy of \>= grade 2 severity. 9. Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis, type A, B or C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC) | up to 165 weeks | Data as of 11 May 2010 cutoff. PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan Meier Estimates of Overall Survival (OS) | up to 177 weeks | Data as of 11 May 2010 cutoff. Overall survival (OS) 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. 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 available, or clinical cut-off date, if it was earlier. |
| Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC) | up to 165 weeks | Data as of 11 May 2010 cutoff. TTP was the time between randomization and disease progression as determined by the CAC. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia. |
| Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Up to 165 weeks | Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus \>=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE). |
| Time to First Response | Up to 66 weeks | Data as of 11 May 2010 cutoff. Time to first response was defined as the time from start of treatment until first response as assessed by the Central Assessment Committee (CMC) based on European Group for Blood and Marrow Transplantation (EBMT) criteria. |
| Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC) | Up to 149 weeks | Data as of 11 May 2010 cutoff. Duration of myeloma response was defined as the time from the initial response date to the earlier of progressive disease (PD) as determined by the CAC or death on study. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia. |
| Kaplan Meier Estimates for Time to Next Antimyeloma Therapy | Up to 168 weeks | Data as of 11 May 2010 cutoff. Time to the next antimyeloma therapy was defined as time from randomization to the start of another non-protocol antimyeloma therapy. Participants 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. |
| Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | Up to 169 weeks (Double-blind therapy period plus 4 weeks) | Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. Dose reduction includes reduction with or without interruption. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning. |
| Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC) | Approximately week 37 (start of cycle 10) to week 165 | Data as of 11 May 2010 cutoff. PFS calculated from the start of the Maintenance period to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems. |
| Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology. |
| Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology. |
| Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. |
| Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image. |
| Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Baseline (Day 0), Months 4, 7, 10, 13, 16 | Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems. |
Countries
Australia, Austria, Belarus, Belgium, Czechia, Denmark, France, Georgia, Germany, Greece, Ireland, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom
Participant flow
Recruitment details
Data represents a May 11, 2010 data cut-off. The study is ongoing.
Pre-assignment details
Of the 606 subjects screened for this study, 147 failed screening. Reasons for screen failures included: laboratory values not met (45 subjects); diagnostic criteria for measurable multiple myeloma not met (30 subjects); other inclusion/exclusion criteria not met (30 subjects); subject withdrawal of consent (14 subjects); and other (28 subjects).
Participants by arm
| Arm | Count |
|---|---|
| MPR+R Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease. | 152 |
| MPR+p Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease. | 153 |
| MPp+p Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease. | 154 |
| Total | 459 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-blind Treatment | Adverse Event | 31 | 27 | 12 |
| Double-blind Treatment | Death | 4 | 4 | 4 |
| Double-blind Treatment | Disease Progression | 47 | 81 | 102 |
| Double-blind Treatment | Lack of Efficacy | 1 | 4 | 2 |
| Double-blind Treatment | Lost to Follow-up | 1 | 0 | 0 |
| Double-blind Treatment | Ongoing in Double-blind Treatment | 45 | 24 | 18 |
| Double-blind Treatment | Other | 7 | 4 | 4 |
| Double-blind Treatment | Protocol Violation | 1 | 0 | 2 |
| Double-blind Treatment | Withdrawal by Subject | 15 | 9 | 10 |
| Follow-up | Death | 21 | 31 | 24 |
| Follow-up | Lost to Follow-up | 2 | 8 | 4 |
| Follow-up | Ongoing in Follow-up Period | 52 | 51 | 60 |
| Open-label Extension | Adverse Event | 1 | 3 | 7 |
| Open-label Extension | Death | 1 | 2 | 4 |
| Open-label Extension | Disease Progression | 8 | 23 | 26 |
| Open-label Extension | Ongoing in Open Label Period | 7 | 15 | 25 |
| Open-label Extension | Other | 0 | 1 | 7 |
| Open-label Extension | Withdrawal by Subject | 2 | 3 | 3 |
Baseline characteristics
| Characteristic | MPp+p | Total | MPR+R | MPR+p |
|---|---|---|---|---|
| Age, Continuous | 72.0 years STANDARD_DEVIATION 5.26 | 72.0 years STANDARD_DEVIATION 5.25 | 72.0 years STANDARD_DEVIATION 5.33 | 72.1 years STANDARD_DEVIATION 5.2 |
| Age, Customized <=75 years | 116 participants | 348 participants | 116 participants | 116 participants |
| Age, Customized >75 years | 38 participants | 111 participants | 36 participants | 37 participants |
| Albumin <= 35 g/L | 72 participants | 205 participants | 63 participants | 70 participants |
| Albumin >35 g/L | 81 participants | 250 participants | 87 participants | 82 participants |
| Albumin Missing | 1 participants | 4 participants | 2 participants | 1 participants |
| Beta2 Microglobulin <=5.5 mg/L | 87 participants | 239 participants | 77 participants | 75 participants |
| Beta2 Microglobulin >5.5 mg/L | 67 participants | 219 participants | 74 participants | 78 participants |
| Beta2 Microglobulin Missing | 0 participants | 1 participants | 1 participants | 0 participants |
| C-reactive Protein <=4 mg/L | 89 participants | 267 participants | 84 participants | 94 participants |
| C-reactive Protein >4 mg/L | 64 participants | 185 participants | 65 participants | 56 participants |
| C-reactive Protein Missing | 1 participants | 7 participants | 3 participants | 3 participants |
| Creatinine clearance <60 ml/min | 76 participants | 223 participants | 78 participants | 69 participants |
| Creatinine clearance >=60 ml/min | 77 participants | 232 participants | 72 participants | 83 participants |
| Creatinine clearance Missing | 1 participants | 4 participants | 2 participants | 1 participants |
| Diastolic Blood Pressure | 78.8 mmHg STANDARD_DEVIATION 10.4 | 78.2 mmHg STANDARD_DEVIATION 9.98 | 78.5 mmHg STANDARD_DEVIATION 9.53 | 77.4 mmHg STANDARD_DEVIATION 9.99 |
| Gender Female | 79 Participants | 231 Participants | 81 Participants | 71 Participants |
| Gender Male | 75 Participants | 228 Participants | 71 Participants | 82 Participants |
| Height | 165.7 centimeter STANDARD_DEVIATION 9.79 | 165.3 centimeter STANDARD_DEVIATION 9.63 | 164.8 centimeter STANDARD_DEVIATION 9.81 | 165.3 centimeter STANDARD_DEVIATION 9.33 |
| International Staging System (ISS) Stage I | 28 participants | 88 participants | 28 participants | 32 participants |
| International Staging System (ISS) Stage II | 48 participants | 145 participants | 50 participants | 47 participants |
| International Staging System (ISS) Stage III | 78 participants | 226 participants | 74 participants | 74 participants |
| Karnofsky Performance Scale | 84.0 units on a scale STANDARD_DEVIATION 11.46 | 82.4 units on a scale STANDARD_DEVIATION 11.74 | 81.1 units on a scale STANDARD_DEVIATION 11.95 | 82.2 units on a scale STANDARD_DEVIATION 11.71 |
| Multiple Myeloma Subtype Immunoglobulin A (IgA) | 33 participants | 110 participants | 39 participants | 38 participants |
| Multiple Myeloma Subtype Missing | 5 participants | 13 participants | 5 participants | 3 participants |
| Multiple Myeloma Subtype Other | 116 participants | 336 participants | 108 participants | 112 participants |
| Plasma Cells in the Bone Marrow | 37.9 percentage of plasma cells STANDARD_DEVIATION 23.65 | 39.0 percentage of plasma cells STANDARD_DEVIATION 24.45 | 39.8 percentage of plasma cells STANDARD_DEVIATION 24.79 | 39.3 percentage of plasma cells STANDARD_DEVIATION 25.01 |
| Pulse | 76.3 beats per minute STANDARD_DEVIATION 10.8 | 76.5 beats per minute STANDARD_DEVIATION 10.36 | 76.0 beats per minute STANDARD_DEVIATION 9.77 | 77.3 beats per minute STANDARD_DEVIATION 10.5 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian / Pacific Islander | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black | 0 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 2 participants | 4 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized White | 151 participants | 453 participants | 151 participants | 151 participants |
| Systolic Blood Pressure | 136.4 mmHg STANDARD_DEVIATION 20.13 | 135.3 mmHg STANDARD_DEVIATION 18.83 | 133.9 mmHg STANDARD_DEVIATION 17.71 | 135.5 mmHg STANDARD_DEVIATION 18.6 |
| Temperature | 36.5 degrees centigrade STANDARD_DEVIATION 0.4 | 36.5 degrees centigrade STANDARD_DEVIATION 0.4 | 36.5 degrees centigrade STANDARD_DEVIATION 0.41 | 36.5 degrees centigrade STANDARD_DEVIATION 0.38 |
| Weight | 72.1 kilograms STANDARD_DEVIATION 15.2 | 72.5 kilograms STANDARD_DEVIATION 14.28 | 73.5 kilograms STANDARD_DEVIATION 14.77 | 72.0 kilograms STANDARD_DEVIATION 12.79 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 149 / 150 | 151 / 152 | 152 / 153 |
| serious Total, serious adverse events | 66 / 150 | 62 / 152 | 56 / 153 |
Outcome results
Primary
Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)
Data as of 11 May 2010 cutoff. PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Time frame: up to 165 weeks
Population: Intent-to-treat population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MPR+R | Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC) | 136.1 weeks |
| MPR+p | Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC) | 62.1 weeks |
| MPp+p | Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC) | 56.1 weeks |
p-value: <0.00195% CI: [0.278, 0.56]Log Rank
p-value: <0.00195% CI: [0.347, 0.702]Log Rank
p-value: 0.13495% CI: [0.589, 1.075]Log Rank
Secondary
Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 13 - approximately Month 13 (n=72,73,82) | -7.2 units on a scale | Standard Deviation 25.91 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 10 - approximately Month 10 (n=85,91,95) | -7.9 units on a scale | Standard Deviation 23 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 4 - approximately Month 4 (n=113,121,127) | -8.9 units on a scale | Standard Deviation 19.56 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 7 - approximately Month 7 (n=96,109,112) | -9.0 units on a scale | Standard Deviation 20.64 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 16 - approximately Month 16 (n=62,51,62) | -10.5 units on a scale | Standard Deviation 23.87 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 10 - approximately Month 10 (n=85,91,95) | -7.1 units on a scale | Standard Deviation 23.85 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 4 - approximately Month 4 (n=113,121,127) | -8.7 units on a scale | Standard Deviation 19.13 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 7 - approximately Month 7 (n=96,109,112) | -9.7 units on a scale | Standard Deviation 23.25 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 13 - approximately Month 13 (n=72,73,82) | -8.8 units on a scale | Standard Deviation 24.9 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 16 - approximately Month 16 (n=62,51,62) | -5.9 units on a scale | Standard Deviation 25.79 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 16 - approximately Month 16 (n=62,51,62) | -3.3 units on a scale | Standard Deviation 20.67 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 13 - approximately Month 13 (n=72,73,82) | -6.3 units on a scale | Standard Deviation 21.84 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 4 - approximately Month 4 (n=113,121,127) | -5.4 units on a scale | Standard Deviation 15.83 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 10 - approximately Month 10 (n=85,91,95) | -5.4 units on a scale | Standard Deviation 18.79 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 7 - approximately Month 7 (n=96,109,112) | -6.0 units on a scale | Standard Deviation 20.81 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 13 - approximately Month 13 (n=68,72,79) | 1.0 units on a scale | Standard Deviation 31.01 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 10 - approximately Month 10 (n=79,83,94) | 7.6 units on a scale | Standard Deviation 33.32 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 4 - approximately Month 4 (n=110,117,119) | 2.1 units on a scale | Standard Deviation 35.36 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 7 - approximately Month 7 (n=88,104,108) | 3.8 units on a scale | Standard Deviation 33.32 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 16 - approximately Month 16 (n=59,52,61) | 3.4 units on a scale | Standard Deviation 32.58 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 10 - approximately Month 10 (n=79,83,94) | -4.0 units on a scale | Standard Deviation 43.69 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 4 - approximately Month 4 (n=110,117,119) | -0.3 units on a scale | Standard Deviation 37.27 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 7 - approximately Month 7 (n=88,104,108) | 2.6 units on a scale | Standard Deviation 37.94 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 13 - approximately Month 13 (n=68,72,79) | -0.5 units on a scale | Standard Deviation 44.23 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 16 - approximately Month 16 (n=59,52,61) | 6.4 units on a scale | Standard Deviation 41.25 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 16 - approximately Month 16 (n=59,52,61) | 2.7 units on a scale | Standard Deviation 28.08 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 13 - approximately Month 13 (n=68,72,79) | 5.1 units on a scale | Standard Deviation 32.51 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 4 - approximately Month 4 (n=110,117,119) | 4.5 units on a scale | Standard Deviation 25.65 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 10 - approximately Month 10 (n=79,83,94) | 3.9 units on a scale | Standard Deviation 26.72 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale | Cycle 7 - approximately Month 7 (n=88,104,108) | 5.2 units on a scale | Standard Deviation 27.78 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 13 - approximately Month 13 (n=71,73,81) | 17.3 units on a scale | Standard Deviation 27.15 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 10 - approximately Month 10 (n=83,88,97) | 17.3 units on a scale | Standard Deviation 27.84 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 4 - approximately Month 4 (n=112,121,124) | 4.7 units on a scale | Standard Deviation 23.74 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 7 - approximately Month 7 (n=93,108,112) | 14.6 units on a scale | Standard Deviation 24.45 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 16 - approximately Month 16 (n=62,52,62) | 18.5 units on a scale | Standard Deviation 25.3 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 10 - approximately Month 10 (n=83,88,97) | 6.6 units on a scale | Standard Deviation 22.4 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 4 - approximately Month 4 (n=112,121,124) | 4.3 units on a scale | Standard Deviation 23.56 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 7 - approximately Month 7 (n=93,108,112) | 7.7 units on a scale | Standard Deviation 23.86 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 13 - approximately Month 13 (n=71,73,81) | 6.3 units on a scale | Standard Deviation 23.78 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 16 - approximately Month 16 (n=62,52,62) | 7.7 units on a scale | Standard Deviation 28.49 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 16 - approximately Month 16 (n=62,52,62) | 14.4 units on a scale | Standard Deviation 26.62 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 13 - approximately Month 13 (n=71,73,81) | 11.9 units on a scale | Standard Deviation 24.67 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 4 - approximately Month 4 (n=112,121,124) | 7.6 units on a scale | Standard Deviation 22.38 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 10 - approximately Month 10 (n=83,88,97) | 14.5 units on a scale | Standard Deviation 21.73 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale | Cycle 7 - approximately Month 7 (n=93,108,112) | 9.8 units on a scale | Standard Deviation 20.62 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 13 - approximately Month 13 (n=72,72,81) | -3.8 units on a scale | Standard Deviation 15.61 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 10 - approximately Month 10 (n=85,89,94) | -1.6 units on a scale | Standard Deviation 14.46 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 4 - approximately Month 4 (n=113,120,125) | 1.3 units on a scale | Standard Deviation 13.37 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 7 - approximately Month 7 (n=95,108,111) | 0.4 units on a scale | Standard Deviation 15.22 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 16 - approximately Month 16 (n=62,50,61) | -2.1 units on a scale | Standard Deviation 14.95 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 10 - approximately Month 10 (n=85,89,94) | 0.0 units on a scale | Standard Deviation 15.99 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 4 - approximately Month 4 (n=113,120,125) | 0.1 units on a scale | Standard Deviation 13.28 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 7 - approximately Month 7 (n=95,108,111) | -1.7 units on a scale | Standard Deviation 14.27 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 13 - approximately Month 13 (n=72,72,81) | -1.0 units on a scale | Standard Deviation 14.59 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 16 - approximately Month 16 (n=62,50,61) | -2.9 units on a scale | Standard Deviation 14.16 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 16 - approximately Month 16 (n=62,50,61) | -0.9 units on a scale | Standard Deviation 12.23 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 13 - approximately Month 13 (n=72,72,81) | 0.3 units on a scale | Standard Deviation 12.6 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 4 - approximately Month 4 (n=113,120,125) | 0.6 units on a scale | Standard Deviation 12.67 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 10 - approximately Month 10 (n=85,89,94) | 0.3 units on a scale | Standard Deviation 12.61 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale | Cycle 7 - approximately Month 7 (n=95,108,111) | 1.8 units on a scale | Standard Deviation 12.94 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale
Data as of 11 May 2010 cutoff. EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 13 - approximately Month 13 (n=70,70,82) | 7.6 units on a scale | Standard Deviation 28.32 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 10 - approximately Month 10 (n=84,86,96) | 12.4 units on a scale | Standard Deviation 25.33 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 4 - approximately Month 4 (n=114,121,125) | 2.3 units on a scale | Standard Deviation 26.13 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 7 - approximately Month 7 (n=96,108,110) | 8.0 units on a scale | Standard Deviation 24.95 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 16 - approximately Month 16 (n=61,50,62) | 10.7 units on a scale | Standard Deviation 25.28 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 10 - approximately Month 10 (n=84,86,96) | 8.8 units on a scale | Standard Deviation 24.7 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 4 - approximately Month 4 (n=114,121,125) | 5.6 units on a scale | Standard Deviation 18.86 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 7 - approximately Month 7 (n=96,108,110) | 8.1 units on a scale | Standard Deviation 22.48 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 13 - approximately Month 13 (n=70,70,82) | 8.8 units on a scale | Standard Deviation 24.02 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 16 - approximately Month 16 (n=61,50,62) | 7.2 units on a scale | Standard Deviation 26.29 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 16 - approximately Month 16 (n=61,50,62) | 8.1 units on a scale | Standard Deviation 25.11 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 13 - approximately Month 13 (n=70,70,82) | 5.4 units on a scale | Standard Deviation 22.8 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 4 - approximately Month 4 (n=114,121,125) | 6.1 units on a scale | Standard Deviation 19.41 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 10 - approximately Month 10 (n=84,86,96) | 6.2 units on a scale | Standard Deviation 24.6 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale | Cycle 7 - approximately Month 7 (n=96,108,110) | 4.2 units on a scale | Standard Deviation 23.92 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 13 - approximately Month 13 (n=75,72,83) | -6.2 units on a scale | Standard Deviation 36.23 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 10 - approximately Month 10 (n=87,93,96) | -5.0 units on a scale | Standard Deviation 33.15 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 4 - approximately Month 4 (n=119,125,130) | 1.7 units on a scale | Standard Deviation 36.54 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 7 - approximately Month 7 (n=99,111,111) | -3.7 units on a scale | Standard Deviation 33.64 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 16 - approximately Month 16 (n=64,52,63) | -7.8 units on a scale | Standard Deviation 36.01 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 10 - approximately Month 10 (n=87,93,96) | -5.4 units on a scale | Standard Deviation 29.2 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 4 - approximately Month 4 (n=119,125,130) | 1.9 units on a scale | Standard Deviation 34.73 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 7 - approximately Month 7 (n=99,111,111) | -5.7 units on a scale | Standard Deviation 31.75 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 13 - approximately Month 13 (n=75,72,83) | -8.8 units on a scale | Standard Deviation 30.13 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 16 - approximately Month 16 (n=64,52,63) | -16.0 units on a scale | Standard Deviation 35.24 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 16 - approximately Month 16 (n=64,52,63) | -6.4 units on a scale | Standard Deviation 28.62 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 13 - approximately Month 13 (n=75,72,83) | -4.8 units on a scale | Standard Deviation 32.15 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 4 - approximately Month 4 (n=119,125,130) | -5.6 units on a scale | Standard Deviation 25.96 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 10 - approximately Month 10 (n=87,93,96) | -8.0 units on a scale | Standard Deviation 29.32 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale | Cycle 7 - approximately Month 7 (n=99,111,111) | -5.7 units on a scale | Standard Deviation 27.66 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 13 - approximately Month 13 (n=73,73,83) | -0.0 units on a scale | Standard Deviation 21.34 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 10 - approximately Month 10 (n=87,92,97) | 1.0 units on a scale | Standard Deviation 22.64 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 4 - approximately Month 4 (n=115,125,128) | 0.3 units on a scale | Standard Deviation 21.51 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 7 - approximately Month 7 (n=98,111,113) | 2.9 units on a scale | Standard Deviation 22.31 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 16 - approximately Month 16 (n=63,52,63) | 0.3 units on a scale | Standard Deviation 22.29 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 10 - approximately Month 10 (n=87,92,97) | -4.4 units on a scale | Standard Deviation 19.89 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 4 - approximately Month 4 (n=115,125,128) | -2.0 units on a scale | Standard Deviation 21.33 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 7 - approximately Month 7 (n=98,111,113) | 0.1 units on a scale | Standard Deviation 17.33 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 13 - approximately Month 13 (n=73,73,83) | -3.0 units on a scale | Standard Deviation 23.78 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 16 - approximately Month 16 (n=63,52,63) | -3.5 units on a scale | Standard Deviation 27.48 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 16 - approximately Month 16 (n=63,52,63) | -4.0 units on a scale | Standard Deviation 18.13 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 13 - approximately Month 13 (n=73,73,83) | -1.4 units on a scale | Standard Deviation 17.69 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 4 - approximately Month 4 (n=115,125,128) | 1.3 units on a scale | Standard Deviation 16.68 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 10 - approximately Month 10 (n=87,92,97) | -2.7 units on a scale | Standard Deviation 20.65 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale | Cycle 7 - approximately Month 7 (n=98,111,113) | 0.7 units on a scale | Standard Deviation 18.42 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 13 - approximately Month 13 (n=73,73,81) | -5.0 units on a scale | Standard Deviation 31.27 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 10 - approximately Month 10 (n=86,93,97) | -5.0 units on a scale | Standard Deviation 34.88 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 4 - approximately Month 4 (n=114,124,128) | -1.8 units on a scale | Standard Deviation 34.31 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 7 - approximately Month 7 (n=96,111,112) | -3.5 units on a scale | Standard Deviation 36.35 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 16 - approximately Month 16 (n=63,51,62) | -1.6 units on a scale | Standard Deviation 31.36 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 10 - approximately Month 10 (n=86,93,97) | -1.1 units on a scale | Standard Deviation 28.43 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 4 - approximately Month 4 (n=114,124,128) | 4.8 units on a scale | Standard Deviation 30.86 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 7 - approximately Month 7 (n=96,111,112) | 0.6 units on a scale | Standard Deviation 30.14 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 13 - approximately Month 13 (n=73,73,81) | -2.7 units on a scale | Standard Deviation 28.74 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 16 - approximately Month 16 (n=63,51,62) | -5.2 units on a scale | Standard Deviation 30.82 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 16 - approximately Month 16 (n=63,51,62) | -2.2 units on a scale | Standard Deviation 32.44 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 13 - approximately Month 13 (n=73,73,81) | -3.3 units on a scale | Standard Deviation 29.16 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 4 - approximately Month 4 (n=114,124,128) | -4.9 units on a scale | Standard Deviation 27.45 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 10 - approximately Month 10 (n=86,93,97) | -1.7 units on a scale | Standard Deviation 26.95 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale | Cycle 7 - approximately Month 7 (n=96,111,112) | -2.7 units on a scale | Standard Deviation 31.05 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 13 - approximately Month 13 (n=73,73,80) | 5.5 units on a scale | Standard Deviation 30.43 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 10 - approximately Month 10 (n=87,92,95) | 1.1 units on a scale | Standard Deviation 22.98 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 4 - approximately Month 4 (n=115,125,124) | 2.3 units on a scale | Standard Deviation 28.85 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 7 - approximately Month 7 (n=98,109,112) | 3.4 units on a scale | Standard Deviation 25.54 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 16 - approximately Month 16 (n=63,52,61) | 10.6 units on a scale | Standard Deviation 35.83 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 10 - approximately Month 10 (n=87,92,95) | 1.4 units on a scale | Standard Deviation 20.91 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 4 - approximately Month 4 (n=115,125,124) | 1.9 units on a scale | Standard Deviation 24.06 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 7 - approximately Month 7 (n=98,109,112) | -1.2 units on a scale | Standard Deviation 23.09 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 13 - approximately Month 13 (n=73,73,80) | -1.4 units on a scale | Standard Deviation 18.78 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 16 - approximately Month 16 (n=63,52,61) | 1.3 units on a scale | Standard Deviation 19.75 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 16 - approximately Month 16 (n=63,52,61) | 0.5 units on a scale | Standard Deviation 17.74 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 13 - approximately Month 13 (n=73,73,80) | 0.8 units on a scale | Standard Deviation 18.35 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 4 - approximately Month 4 (n=115,125,124) | 3.2 units on a scale | Standard Deviation 25.65 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 10 - approximately Month 10 (n=87,92,95) | -0.0 units on a scale | Standard Deviation 21.19 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale | Cycle 7 - approximately Month 7 (n=98,109,112) | 0.9 units on a scale | Standard Deviation 22.13 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 13 - approximately Month 13 (n=73,73,81) | -5.0 units on a scale | Standard Deviation 30.26 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 10 - approximately Month 10 (n=86,93,96) | -4.3 units on a scale | Standard Deviation 30.6 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 4 - approximately Month 4 (n=117,126,126) | -2.6 units on a scale | Standard Deviation 29.74 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 7 - approximately Month 7 (n=100,110,110) | -1.7 units on a scale | Standard Deviation 28.18 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 16 - approximately Month 16 (n=62,53,62) | -3.2 units on a scale | Standard Deviation 29.39 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 10 - approximately Month 10 (n=86,93,96) | -4.3 units on a scale | Standard Deviation 35.87 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 4 - approximately Month 4 (n=117,126,126) | -6.4 units on a scale | Standard Deviation 32.04 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 7 - approximately Month 7 (n=100,110,110) | -8.5 units on a scale | Standard Deviation 32.07 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 13 - approximately Month 13 (n=73,73,81) | -2.3 units on a scale | Standard Deviation 30.6 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 16 - approximately Month 16 (n=62,53,62) | -6.3 units on a scale | Standard Deviation 32.07 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 16 - approximately Month 16 (n=62,53,62) | 1.6 units on a scale | Standard Deviation 22.92 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 13 - approximately Month 13 (n=73,73,81) | -0.0 units on a scale | Standard Deviation 22.35 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 4 - approximately Month 4 (n=117,126,126) | -0.0 units on a scale | Standard Deviation 23.48 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 10 - approximately Month 10 (n=86,93,96) | 3.8 units on a scale | Standard Deviation 25.07 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale | Cycle 7 - approximately Month 7 (n=100,110,110) | 2.1 units on a scale | Standard Deviation 20.82 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 13 - approximately Month 13 (n=73,73,83) | 8.2 units on a scale | Standard Deviation 24.59 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 10 - approximately Month 10 (n=86,92,97) | 9.0 units on a scale | Standard Deviation 23.28 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 4 - approximately Month 4 (n=115,125,128) | 4.8 units on a scale | Standard Deviation 25 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 7 - approximately Month 7 (n=98,111,112) | 8.8 units on a scale | Standard Deviation 24.94 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 16 - approximately Month 16 (n=63,52,63) | 9.9 units on a scale | Standard Deviation 23.23 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 10 - approximately Month 10 (n=86,92,97) | 1.6 units on a scale | Standard Deviation 22.07 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 4 - approximately Month 4 (n=115,125,128) | 2.7 units on a scale | Standard Deviation 22.59 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 7 - approximately Month 7 (n=98,111,112) | 4.2 units on a scale | Standard Deviation 20.38 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 13 - approximately Month 13 (n=73,73,83) | 1.1 units on a scale | Standard Deviation 21.78 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 16 - approximately Month 16 (n=63,52,63) | -0.2 units on a scale | Standard Deviation 21.57 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 16 - approximately Month 16 (n=63,52,63) | 6.9 units on a scale | Standard Deviation 19.72 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 13 - approximately Month 13 (n=73,73,83) | 6.6 units on a scale | Standard Deviation 21.78 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 4 - approximately Month 4 (n=115,125,128) | 6.8 units on a scale | Standard Deviation 18.75 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 10 - approximately Month 10 (n=86,92,97) | 4.7 units on a scale | Standard Deviation 22.05 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale | Cycle 7 - approximately Month 7 (n=98,111,112) | 5.0 units on a scale | Standard Deviation 21.56 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 13 - approximately Month 13 (n=74,74,82) | -7.1 units on a scale | Standard Deviation 26.08 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 10 - approximately Month 10 (n=87,95,95) | -7.5 units on a scale | Standard Deviation 27.31 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 4 - approximately Month 4 (n=120,127,129) | -3.0 units on a scale | Standard Deviation 25.61 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 7 - approximately Month 7 (n=100,112,110) | -7.6 units on a scale | Standard Deviation 23 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 16 - approximately Month 16 (n=64,53,62) | -10.0 units on a scale | Standard Deviation 26.86 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 10 - approximately Month 10 (n=87,95,95) | -7.5 units on a scale | Standard Deviation 29.78 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 4 - approximately Month 4 (n=120,127,129) | -5.5 units on a scale | Standard Deviation 24.08 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 7 - approximately Month 7 (n=100,112,110) | -9.5 units on a scale | Standard Deviation 25.97 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 13 - approximately Month 13 (n=74,74,82) | -10.7 units on a scale | Standard Deviation 30.33 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 16 - approximately Month 16 (n=64,53,62) | -9.7 units on a scale | Standard Deviation 28.77 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 16 - approximately Month 16 (n=64,53,62) | -4.1 units on a scale | Standard Deviation 26.34 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 13 - approximately Month 13 (n=74,74,82) | -7.5 units on a scale | Standard Deviation 27.29 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 4 - approximately Month 4 (n=120,127,129) | -5.1 units on a scale | Standard Deviation 24.33 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 10 - approximately Month 10 (n=87,95,95) | -6.9 units on a scale | Standard Deviation 28.31 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale | Cycle 7 - approximately Month 7 (n=100,112,110) | -5.7 units on a scale | Standard Deviation 27.32 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 13 - approximately Month 13 (n=70,72,83) | 4.8 units on a scale | Standard Deviation 21.45 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 10 - approximately Month 10 (n=84,92,97) | 6.0 units on a scale | Standard Deviation 21.44 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 4 - approximately Month 4 (n=111,123,125) | 2.4 units on a scale | Standard Deviation 24.91 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 7 - approximately Month 7 (n=94,111,112) | 2.1 units on a scale | Standard Deviation 23.85 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 16 - approximately Month 16 (n=61,52,63) | 1.6 units on a scale | Standard Deviation 20.58 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 10 - approximately Month 10 (n=84,92,97) | 0.7 units on a scale | Standard Deviation 28.81 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 4 - approximately Month 4 (n=111,123,125) | -1.1 units on a scale | Standard Deviation 19.06 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 7 - approximately Month 7 (n=94,111,112) | -0.6 units on a scale | Standard Deviation 28.07 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 13 - approximately Month 13 (n=70,72,83) | -0.5 units on a scale | Standard Deviation 28.8 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 16 - approximately Month 16 (n=61,52,63) | -0.6 units on a scale | Standard Deviation 35.24 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 16 - approximately Month 16 (n=61,52,63) | -5.3 units on a scale | Standard Deviation 30.06 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 13 - approximately Month 13 (n=70,72,83) | -4.0 units on a scale | Standard Deviation 26.75 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 4 - approximately Month 4 (n=111,123,125) | -2.9 units on a scale | Standard Deviation 18.93 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 10 - approximately Month 10 (n=84,92,97) | -1.7 units on a scale | Standard Deviation 19.47 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale | Cycle 7 - approximately Month 7 (n=94,111,112) | -2.1 units on a scale | Standard Deviation 22.5 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 13 - approximately Month 13 (n=75,73,83) | -4.9 units on a scale | Standard Deviation 29.86 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 10 - approximately Month 10 (n=87,94,96) | -5.0 units on a scale | Standard Deviation 28.99 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 4 - approximately Month 4 (n=118,124,128) | 2.0 units on a scale | Standard Deviation 33.56 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 7 - approximately Month 7 (n=100,109,111) | -1.0 units on a scale | Standard Deviation 29.76 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | -4.7 units on a scale | Standard Deviation 32.46 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 10 - approximately Month 10 (n=87,94,96) | -2.5 units on a scale | Standard Deviation 25.04 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 4 - approximately Month 4 (n=118,124,128) | -1.6 units on a scale | Standard Deviation 31.77 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 7 - approximately Month 7 (n=100,109,111) | -6.4 units on a scale | Standard Deviation 27.02 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 13 - approximately Month 13 (n=75,73,83) | 0.9 units on a scale | Standard Deviation 29.38 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | -0.6 units on a scale | Standard Deviation 32.36 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | -3.7 units on a scale | Standard Deviation 31.18 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 13 - approximately Month 13 (n=75,73,83) | -6.8 units on a scale | Standard Deviation 29.8 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 4 - approximately Month 4 (n=118,124,128) | -5.0 units on a scale | Standard Deviation 27.77 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 10 - approximately Month 10 (n=87,94,96) | -1.7 units on a scale | Standard Deviation 32.58 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale | Cycle 7 - approximately Month 7 (n=100,109,111) | -5.7 units on a scale | Standard Deviation 32.06 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 13 - approximately Month 13 (n=75,72,83) | 0.7 units on a scale | Standard Deviation 13.55 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 10 - approximately Month 10 (n=87,95,97) | 1.9 units on a scale | Standard Deviation 16.75 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 4 - approximately Month 4 (n=120,127,130) | 3.3 units on a scale | Standard Deviation 19.4 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 7 - approximately Month 7 (n=99,112,112) | 0.5 units on a scale | Standard Deviation 14.57 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 16 - approximately Month 16 (n=64,52,62) | 1.0 units on a scale | Standard Deviation 12.9 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 10 - approximately Month 10 (n=87,95,97) | -1.4 units on a scale | Standard Deviation 19.4 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 4 - approximately Month 4 (n=120,127,130) | -1.3 units on a scale | Standard Deviation 17.14 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 7 - approximately Month 7 (n=99,112,112) | -0.7 units on a scale | Standard Deviation 19.94 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 13 - approximately Month 13 (n=75,72,83) | -3.0 units on a scale | Standard Deviation 19.65 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 16 - approximately Month 16 (n=64,52,62) | -4.2 units on a scale | Standard Deviation 18.65 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 16 - approximately Month 16 (n=64,52,62) | -1.3 units on a scale | Standard Deviation 9.21 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 13 - approximately Month 13 (n=75,72,83) | -0.4 units on a scale | Standard Deviation 12.48 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 4 - approximately Month 4 (n=120,127,130) | -0.0 units on a scale | Standard Deviation 17.36 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 10 - approximately Month 10 (n=87,95,97) | 0.3 units on a scale | Standard Deviation 14.23 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale | Cycle 7 - approximately Month 7 (n=99,112,112) | 0.7 units on a scale | Standard Deviation 14.73 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 13 - approximately Month 13 (n=74,74,83) | -13.7 units on a scale | Standard Deviation 40.48 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 10 - approximately Month 10 (n=88,95,97) | -17.2 units on a scale | Standard Deviation 34.78 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 4 - approximately Month 4 (n=120,127,129) | -14.4 units on a scale | Standard Deviation 32.76 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 7 - approximately Month 7 (n=100,112,113) | -17.8 units on a scale | Standard Deviation 36.18 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | -20.3 units on a scale | Standard Deviation 33.92 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 10 - approximately Month 10 (n=88,95,97) | -15.6 units on a scale | Standard Deviation 35.3 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 4 - approximately Month 4 (n=120,127,129) | -13.8 units on a scale | Standard Deviation 33.6 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 7 - approximately Month 7 (n=100,112,113) | -16.5 units on a scale | Standard Deviation 33.45 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 13 - approximately Month 13 (n=74,74,83) | -14.9 units on a scale | Standard Deviation 33.28 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | -11.0 units on a scale | Standard Deviation 33 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | -12.2 units on a scale | Standard Deviation 29.96 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 13 - approximately Month 13 (n=74,74,83) | -12.1 units on a scale | Standard Deviation 27.46 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 4 - approximately Month 4 (n=120,127,129) | -13.4 units on a scale | Standard Deviation 29.32 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 10 - approximately Month 10 (n=88,95,97) | -9.8 units on a scale | Standard Deviation 31.71 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale | Cycle 7 - approximately Month 7 (n=100,112,113) | -11.5 units on a scale | Standard Deviation 33.49 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 13 - approximately Month 13 (n=75,74,83) | 8.6 units on a scale | Standard Deviation 24.04 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 10 - approximately Month 10 (n=88,95,96) | 8.9 units on a scale | Standard Deviation 22.75 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 4 - approximately Month 4 (n=120,127,130) | 1.9 units on a scale | Standard Deviation 23.72 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 7 - approximately Month 7 (n=100,112,112) | 8.2 units on a scale | Standard Deviation 22.71 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | 10.0 units on a scale | Standard Deviation 25 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 10 - approximately Month 10 (n=88,95,96) | 8.5 units on a scale | Standard Deviation 25.62 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 4 - approximately Month 4 (n=120,127,130) | 3.3 units on a scale | Standard Deviation 21.64 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 7 - approximately Month 7 (n=100,112,112) | 8.1 units on a scale | Standard Deviation 20.54 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 13 - approximately Month 13 (n=75,74,83) | 9.7 units on a scale | Standard Deviation 25.39 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | 7.6 units on a scale | Standard Deviation 22.66 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | 1.1 units on a scale | Standard Deviation 19.3 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 13 - approximately Month 13 (n=75,74,83) | 3.3 units on a scale | Standard Deviation 20.3 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 4 - approximately Month 4 (n=120,127,130) | 4.5 units on a scale | Standard Deviation 18.68 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 10 - approximately Month 10 (n=88,95,96) | 5.1 units on a scale | Standard Deviation 20.42 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale | Cycle 7 - approximately Month 7 (n=100,112,112) | 2.7 units on a scale | Standard Deviation 23.2 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 13 - approximately Month 13 (n=74,74,82) | 9.7 units on a scale | Standard Deviation 40.36 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 10 - approximately Month 10 (n=86,95,95) | 9.3 units on a scale | Standard Deviation 35.76 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 4 - approximately Month 4 (n=119,127,130) | 1.8 units on a scale | Standard Deviation 33.18 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 7 - approximately Month 7 (n=99,112,113) | 5.7 units on a scale | Standard Deviation 35.57 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | 12.2 units on a scale | Standard Deviation 40.09 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 10 - approximately Month 10 (n=86,95,95) | 7.5 units on a scale | Standard Deviation 36.29 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 4 - approximately Month 4 (n=119,127,130) | 3.0 units on a scale | Standard Deviation 30.75 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 7 - approximately Month 7 (n=99,112,113) | 8.0 units on a scale | Standard Deviation 32.42 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 13 - approximately Month 13 (n=74,74,82) | 11.7 units on a scale | Standard Deviation 33.42 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | 8.5 units on a scale | Standard Deviation 34.22 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 16 - approximately Month 16 (n=64,53,63) | 7.1 units on a scale | Standard Deviation 31.93 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 13 - approximately Month 13 (n=74,74,82) | 5.7 units on a scale | Standard Deviation 30.68 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 4 - approximately Month 4 (n=119,127,130) | 7.4 units on a scale | Standard Deviation 26.34 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 10 - approximately Month 10 (n=86,95,95) | 5.6 units on a scale | Standard Deviation 31.29 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale | Cycle 7 - approximately Month 7 (n=99,112,113) | 6.9 units on a scale | Standard Deviation 31.16 |
Secondary
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.
Time frame: Baseline (Day 0), Months 4, 7, 10, 13, 16
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 13 - approximately Month 13 (n=72,73,83) | 11.8 units on a scale | Standard Deviation 32.91 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 10 - approximately Month 10 (n=87,92,97) | 10.9 units on a scale | Standard Deviation 34.27 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 4 - approximately Month 4 (n=115,125,127) | 5.1 units on a scale | Standard Deviation 35.05 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 7 - approximately Month 7 (n=98,111,112) | 8.3 units on a scale | Standard Deviation 33.87 |
| MPR+R | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 16 - approximately Month 16 (n=63,52,63) | 13.2 units on a scale | Standard Deviation 33.35 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 10 - approximately Month 10 (n=87,92,97) | 4.5 units on a scale | Standard Deviation 29.87 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 4 - approximately Month 4 (n=115,125,127) | 0.3 units on a scale | Standard Deviation 26.6 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 7 - approximately Month 7 (n=98,111,112) | 4.4 units on a scale | Standard Deviation 24.48 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 13 - approximately Month 13 (n=72,73,83) | 7.5 units on a scale | Standard Deviation 29.8 |
| MPR+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 16 - approximately Month 16 (n=63,52,63) | 6.1 units on a scale | Standard Deviation 30.79 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 16 - approximately Month 16 (n=63,52,63) | 9.8 units on a scale | Standard Deviation 28.66 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 13 - approximately Month 13 (n=72,73,83) | 6.2 units on a scale | Standard Deviation 27.63 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 4 - approximately Month 4 (n=115,125,127) | 6.0 units on a scale | Standard Deviation 22.78 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 10 - approximately Month 10 (n=87,92,97) | 4.1 units on a scale | Standard Deviation 27.22 |
| MPp+p | Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale | Cycle 7 - approximately Month 7 (n=98,111,112) | 6.1 units on a scale | Standard Deviation 26.57 |
Secondary
Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)
Data as of 11 May 2010 cutoff. Duration of myeloma response was defined as the time from the initial response date to the earlier of progressive disease (PD) as determined by the CAC or death on study. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Time frame: Up to 149 weeks
Population: Population: Participants who achieved a partial response (PR) or complete response (CR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MPR+R | Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC) | 121.6 weeks |
| MPR+p | Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC) | 56.1 weeks |
| MPp+p | Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC) | 55.4 weeks |
p-value: <0.00195% CI: [0.228, 0.531]Log Rank
p-value: <0.00195% CI: [0.281, 0.623]Log Rank
p-value: 0.30295% CI: [0.571, 1.191]Log Rank
Secondary
Kaplan Meier Estimates for Time to Next Antimyeloma Therapy
Data as of 11 May 2010 cutoff. Time to the next antimyeloma therapy was defined as time from randomization to the start of another non-protocol antimyeloma therapy. Participants 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.
Time frame: Up to 168 weeks
Population: Intent to treat population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MPR+R | Kaplan Meier Estimates for Time to Next Antimyeloma Therapy | 128.9 weeks |
| MPR+p | Kaplan Meier Estimates for Time to Next Antimyeloma Therapy | 66.1 weeks |
| MPp+p | Kaplan Meier Estimates for Time to Next Antimyeloma Therapy | 66.3 weeks |
p-value: <0.00195% CI: [0.296, 0.553]Log Rank
p-value: <0.00195% CI: [0.363, 0.688]Log Rank
p-value: 0.16995% CI: [0.63, 1.085]Log Rank
Secondary
Kaplan Meier Estimates of Overall Survival (OS)
Data as of 11 May 2010 cutoff. Overall survival (OS) 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. 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 available, or clinical cut-off date, if it was earlier.
Time frame: up to 177 weeks
Population: Intent to treat population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MPR+R | Kaplan Meier Estimates of Overall Survival (OS) | NA weeks |
| MPR+p | Kaplan Meier Estimates of Overall Survival (OS) | NA weeks |
| MPp+p | Kaplan Meier Estimates of Overall Survival (OS) | NA weeks |
Secondary
Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)
Data as of 11 May 2010 cutoff. PFS calculated from the start of the Maintenance period to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Time frame: Approximately week 37 (start of cycle 10) to week 165
Population: Intent to treat (ITT) population of participants in Arms MPR+R and MPR+p who entered maintenance within the Double-blind Treatment Period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MPR+R | Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC) | 112.0 weeks |
| MPR+p | Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC) | 32.3 weeks |
p-value: <0.00195% CI: [0.214, 0.541]Log Rank
Secondary
Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)
Data as of 11 May 2010 cutoff. TTP was the time between randomization and disease progression as determined by the CAC. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Time frame: up to 165 weeks
Population: Intent to treat population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MPR+R | Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC) | 148.1 weeks |
| MPR+p | Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC) | 62.7 weeks |
| MPp+p | Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC) | 61.3 weeks |
p-value: <0.00195% CI: [0.231, 0.493]Log Rank
p-value: <0.00195% CI: [0.284, 0.603]Log Rank
p-value: 0.22395% CI: [0.606, 1.125]Log Rank
Secondary
Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period
Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus \>=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE).
Time frame: Up to 165 weeks
Population: Intent to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MPR+R | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Progressive disease (PD) | 0 participants |
| MPR+R | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Stable disease (SD) | 28 participants |
| MPR+R | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Complete response (CR) | 15 participants |
| MPR+R | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Partial response (PR) | 102 participants |
| MPR+R | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Response not evaluable (NE) | 7 participants |
| MPR+p | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Stable disease (SD) | 40 participants |
| MPR+p | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Complete response (CR) | 5 participants |
| MPR+p | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Partial response (PR) | 99 participants |
| MPR+p | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Progressive disease (PD) | 2 participants |
| MPR+p | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Response not evaluable (NE) | 7 participants |
| MPp+p | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Response not evaluable (NE) | 7 participants |
| MPp+p | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Progressive disease (PD) | 0 participants |
| MPp+p | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Complete response (CR) | 5 participants |
| MPp+p | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Stable disease (SD) | 70 participants |
| MPp+p | Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period | Partial response (PR) | 72 participants |
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: 0.009Wilcoxon (Mann-Whitney)
p-value: 0.003Wilcoxon (Mann-Whitney)
Comparison: Based on dichotomized response: 1) CR or PR 2) SD or PD or NEp-value: <0.00195% CI: [2.04, 5.47]Fisher Exact
Comparison: Based on dichotomized response: 1) CR or PR 2) SD or PD or NEp-value: 0.09695% CI: [0.95, 2.62]Fisher Exact
Comparison: Based on dichotomized response: 1) CR or PR 2) SD or PD or NEp-value: 0.00295% CI: [1.33, 3.37]Fisher Exact
Secondary
Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period
Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. Dose reduction includes reduction with or without interruption.
Time frame: Up to 169 weeks (Double-blind therapy period plus 4 weeks)
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 serious AE (SAE) | 66 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Lenalidomide/Placebo withdrawal | 26 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 3-4 AE related to Prednisone | 32 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Prednisone dose interruption | 28 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 adverse event (AE) | 150 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 5 AE related to Lenalidomide/Placebo | 3 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Prednisone dose reduction | 15 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 SAE related to Prednisone | 19 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 5 AE related to Melphalan | 3 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE related to Lenaldomide/Placebo | 148 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 SAE related to Melphalan | 27 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 5 AE related to Prednisone | 1 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Melphalan dose interruption | 5 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 SAE related to Lenalidomide/Placebo | 38 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Melphalan dose reduction | 47 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE related to Melphalan | 140 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 CTCAE grade 5 AE | 7 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Lenalidomide/Plac dose reduction | 71 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1AE related to Prednisone | 87 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 CTCAE grade 3-4 AE | 137 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Prednisone withdrawal | 20 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 3-4 AE related to Lenaldomide/Placebo | 128 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Lenalidomide/Plac dose interrupt | 92 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Melphalan withdrawal | 20 participants |
| MPR+R | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 3-4 AE related to Melphalan | 118 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 SAE related to Prednisone | 16 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 adverse event (AE) | 151 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 CTCAE grade 3-4 AE | 129 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 CTCAE grade 5 AE | 6 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 serious AE (SAE) | 62 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE related to Lenaldomide/Placebo | 145 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE related to Melphalan | 134 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1AE related to Prednisone | 94 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 3-4 AE related to Lenaldomide/Placebo | 117 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 3-4 AE related to Melphalan | 110 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 3-4 AE related to Prednisone | 29 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 5 AE related to Lenalidomide/Placebo | 2 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 5 AE related to Melphalan | 1 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 5 AE related to Prednisone | 1 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 SAE related to Lenalidomide/Placebo | 32 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 SAE related to Melphalan | 24 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Lenalidomide/Placebo withdrawal | 24 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Melphalan withdrawal | 19 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Prednisone withdrawal | 19 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Lenalidomide/Plac dose reduction | 70 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Melphalan dose reduction | 58 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Prednisone dose reduction | 7 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Lenalidomide/Plac dose interrupt | 82 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Melphalan dose interruption | 1 participants |
| MPR+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Prednisone dose interruption | 39 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Lenalidomide/Placebo withdrawal | 14 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 3-4 AE related to Lenaldomide/Placebo | 68 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 adverse event (AE) | 153 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Melphalan withdrawal | 10 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1AE related to Prednisone | 93 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Lenalidomide/Plac dose interrupt | 51 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Prednisone withdrawal | 10 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE related to Melphalan | 126 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 CTCAE grade 3-4 AE | 107 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Lenalidomide/Plac dose reduction | 26 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE related to Lenaldomide/Placebo | 131 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Prednisone dose interruption | 15 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Melphalan dose reduction | 21 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 serious AE (SAE) | 56 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 5 AE related to Prednisone | 1 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Melphalan dose interruption | 0 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 SAE related to Lenalidomide/Placebo | 11 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 5 AE related to Melphalan | 3 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 AE leading to Prednisone dose reduction | 5 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 SAE related to Melphalan | 11 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 5 AE related to Lenalidomide/Placebo | 2 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 3-4 AE related to Prednisone | 22 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 SAE related to Prednisone | 5 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 Grade 3-4 AE related to Melphalan | 62 participants |
| MPp+p | Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period | >=1 CTCAE grade 5 AE | 7 participants |
Secondary
Time to First Response
Data as of 11 May 2010 cutoff. Time to first response was defined as the time from start of treatment until first response as assessed by the Central Assessment Committee (CMC) based on European Group for Blood and Marrow Transplantation (EBMT) criteria.
Time frame: Up to 66 weeks
Population: Participants who had a partial response (PR) or complete response (CR)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MPR+R | Time to First Response | 10.0 weeks | Standard Deviation 7.4 |
| MPR+p | Time to First Response | 9.3 weeks | Standard Deviation 6.55 |
| MPp+p | Time to First Response | 16.2 weeks | Standard Deviation 11.59 |