Phase 3
Completed N=459
A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.
Source: ClinicalTrials.gov NCT00405756 ↗Enrolled (actual)
459
Serious AEs
40.4%
Results posted
May 2012
Primary outcomePrimary: Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC) — 136.1; 62.1; 56.1 weeks — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC) |
136.1; 62.1; 56.1 | <0.001 sig |
| 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) |
112.0; 32.3 | <0.001 sig |
| SECONDARY Kaplan Meier Estimates of Overall Survival (OS) |
NA; NA; NA | — |
| SECONDARY Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC) |
148.1; 62.7; 61.3 | <0.001 sig |
| SECONDARY Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period |
15; 5; 5; 102; 99; 72 | <0.001 sig |
| SECONDARY Time to First Response |
10.0; 9.3; 16.2 | — |
| SECONDARY Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC) |
121.6; 56.1; 55.4 | <0.001 sig |
| SECONDARY Kaplan Meier Estimates for Time to Next Antimyeloma Therapy |
128.9; 66.1; 66.3 | <0.001 sig |
| SECONDARY Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period |
150; 151; 153; 137; 129; 107 | — |
| 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 |
2.3; 5.6; 6.1; 8.0; 8.1; 4.2 | — |
| 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) Physical Functioning Scale |
1.9; 3.3; 4.5; 8.2; 8.1; 2.7 | — |
| 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 |
1.8; 3.0; 7.4; 5.7; 8.0; 6.9 | — |
| 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 |
4.8; 2.7; 6.8; 8.8; 4.2; 5.0 | — |
| 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 |
0.3; -2.0; 1.3; 2.9; 0.1; 0.7 | — |
| 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 |
5.1; 0.3; 6.0; 8.3; 4.4; 6.1 | — |
| 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 |
-3.0; -5.5; -5.1; -7.6; -9.5; -5.7 | — |
| 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 |
3.3; -1.3; -0.0; 0.5; -0.7; 0.7 | — |
| 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 |
-14.4; -13.8; -13.4; -17.8; -16.5; -11.5 | — |
| 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) Dyspnoea Scale |
-2.6; -6.4; -0.0; -1.7; -8.5; 2.1 | — |
| 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 |
2.0; -1.6; -5.0; -1.0; -6.4; -5.7 | — |
| 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 |
1.7; 1.9; -5.6; -3.7; -5.7; -5.7 | — |
| 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 |
-1.8; 4.8; -4.9; -3.5; 0.6; -2.7 | — |
| 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 |
2.3; 1.9; 3.2; 3.4; -1.2; 0.9 | — |
| 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 |
2.4; -1.1; -2.9; 2.1; -0.6; -2.1 | — |
| 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 |
-8.9; -8.7; -5.4; -9.0; -9.7; -6.0 | — |
| 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 |
1.3; 0.1; 0.6; 0.4; -1.7; 1.8 | — |
| 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 |
4.7; 4.3; 7.6; 14.6; 7.7; 9.8 | — |
| 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 |
2.1; -0.3; 4.5; 3.8; 2.6; 5.2 | — |
Eligibility Criteria
Inclusion Criteria
- Must understand and voluntarily sign an informed consent form
- Age greater than or equal to 65 years at the time of signing the informed consent
- Newly diagnosed with symptomatic multiple myeloma as defined by the 3 criteria below:
MM diagnostic criteria (all of next 3 required)
- Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma
- Monoclonal protein present in the serum and/or urine
- Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2mg/dl) [A] Anemia (hemoglobin = 50% of bone marrow nucleated cells are plasma cells Haemoglobin 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)
- 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)
- Neuropathy of >= grade 2 severity.
- Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis, type A, B or C.
Data sourced from ClinicalTrials.gov (NCT00405756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.