A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

NCT00420849 | Completed Phase 3 Results

• 2 other identifiers: CC-5013-MM-0182006-002517-12
• Study Type: interventional
• Target: 587
• Locations: 4 countries
• Sites: 4

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment

  Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.

  up to 123 weeks

Secondary Outcomes (23)

• Participants With Adverse Events of Special Interest: Peripheral Neuropathy

  up to 124 weeks

• Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)

  up to 124 weeks

• Participants With Adverse Events of Special Interest: Venous Thromboembolic Events

  up to 124 weeks

• Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)

  up to 124 weeks

• 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

  Baseline (Day 0), Week 24

Study Arms (1)

Lenalidomide plus Dexamethasone

EXPERIMENTAL

Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Lenalidomide DRUG

Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression, drug became commercially available or limited to 6 treatment cycles.

Also known as: Revlimid

Lenalidomide plus Dexamethasone

Dexamethasone DRUG

Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4. Beginning cycle 5, a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

Lenalidomide plus Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating females

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (5)

The Mater Private Centre for Haematology & Oncology

South Brisbane, QLD 4101, Australia

Location

Wilhelminenspital

Vienna, Montlearstrasse 37, 1160, Austria

Location

St James's Hospital

Dublin, Ireland

Location

H. Clínico de Salamanca

Salamanca, Spain

Location

Royal Free Hospital & Medical School

London, NW3 2QG, United Kingdom

Location

Related Publications (2)

• 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.

  RESULT

• 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.

  PMID: 22292853 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

This study was defined primarily as an expanded access program in the selected countries. Treatment was to continue until disease progression, study drug was discontinued for any reason, or lenalidomide became commercially available for indication.

Results Point of Contact

• Title: Associate Director, Clinical Trials Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Study Officials

• Robert Knight, MD

  Celgene Therapeutic Area Head

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: November 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 21, 2012
• Results First Posted: March 14, 2012

Record last verified: 2012-05

Locations

ES (1); GB (1); AU (1); IE (1)