Phase 3
Completed N=587
A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Source: ClinicalTrials.gov NCT00420849 ↗Enrolled (actual)
587
Serious AEs
57.9%
Results posted
Mar 2012
Primary outcomePrimary: Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment — 586; 519; 471; 340 participants
Summary
This is a multi-centre, single-arm treatment study combining lenalidomide plus high dose dexamethasone.
Subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone in 4 week cycles. Subjects will be seen every 2 weeks for the first 3 cycles of therapy and then every 4 weeks after the third cycle until disease progression is documented, study drug is discontinued for any reason or lenalidomide becomes commercially available for this indication. Assessments of safety and quality of life are performed during the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment |
586; 519; 471; 340 | — |
| SECONDARY Participants With Adverse Events of Special Interest: Peripheral Neuropathy |
84; 46; 33; 5; 2; 2 | — |
| SECONDARY Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE) |
25.6 | — |
| SECONDARY Participants With Adverse Events of Special Interest: Venous Thromboembolic Events |
60; 38; 23; 7; 1 | — |
| SECONDARY Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE) |
26.5 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale |
-3.6; -2.9; -1.8 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale |
-2.4; -1.5; -2.6 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale |
-0.2; -4.0; -0.7 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale |
-1.9; -4.9; 3.5 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale |
-5.2; -5.3; -3.1 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale |
2.6; 5.3; 1.0 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale |
-3.9; -5.2; -6.6 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale |
1.0; 0.1; -2.2 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale |
1.1; 7.9; 2.6 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale |
8.6; 8.1; 9.0 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale |
-3.8; 2.2; -1.8 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale |
2.7; 2.7; -0.9 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale |
0.4; 3.3; -4.5 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale |
2.0; 0.8; 0.9 | — |
| SECONDARY Change From Baseline to Week 24 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 |
1.1; -1.8; -2.2 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale |
-2.4; -1.2; -3.9 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale |
4.9; 4.7; 2.0 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale |
5.8; 3.4; 4.4 | — |
| SECONDARY Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale |
-4.3; -2.0; -5.3 | — |
Eligibility Criteria
Inclusion Criteria
- Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment.
- Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to baseline.
- Females of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence.
Exclusion Criteria
- Pregnant or lactating females
Data sourced from ClinicalTrials.gov (NCT00420849). 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.