Clinical trial NCT00420849: A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Official title: A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 587
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment
timeFrame: up to 123 weeks
Secondary outcomes:
measure: Participants With Adverse Events of Special Interest: Peripheral Neuropathy
timeFrame: up to 124 weeks
measure: Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)
timeFrame: up to 124 weeks
measure: Participants With Adverse Events of Special Interest: Venous Thromboembolic Events
timeFrame: up to 124 weeks
measure: Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)
timeFrame: up to 124 weeks
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
measure: 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
timeFrame: Baseline (Day 0), Week 24
Other outcomes:
Locations:
city: South Brisbane
country: Australia
facility: The Mater Private Centre for Haematology & Oncology
city: Vienna
country: Austria
facility: Wilhelminenspital
state: Montlearstrasse 37
city: Dublin
country: Ireland
facility: St James's Hospital
city: Salamanca
country: Spain
facility: H. Clínico de Salamanca
city: London
country: United Kingdom
facility: Royal Free Hospital & Medical School
Study officials:
affiliation: Celgene Therapeutic Area Head
name: Robert Knight, MD
role: STUDY_DIRECTOR
References:
citation: Yong K, Alegre Amor A, Browne P, Cavenagh J, Dodds T, Greil R, et al. A Multicenter, Single-arm, Open-label Safety and Quality of Life Study of Lenalidomide plus Dexamethasone in previously treated Patients with Multiple Myeloma. Haematologica 2010;95(suppl.2):392, abs. 0944.
citation: Alegre A, Oriol-Rocafiguera A, Garcia-Larana J, Mateos MV, Sureda A, Martinez-Chamorro C, Cibeira MT, Aguado B, Knight R, Rosettani B. Efficacy, safety and quality-of-life associated with lenalidomide plus dexamethasone for the treatment of relapsed or refractory multiple myeloma: the Spanish experience. Leuk Lymphoma. 2012 Sep;53(9):1714-21. doi: 10.3109/10428194.2012.662643. Epub 2012 Mar 1.