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

This study is ongoing, but not recruiting participants.

First Received: January 9, 2007 Last Updated: September 18, 2007 History of Changes

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00420849

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Lenalidomide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Multicentre, Single-Arm, Open-Label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Lenalidomide CC 5013 Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

To provide Lenalidomide to subjects with a high likelihood of benefit.

Secondary Outcome Measures:

Safety
Quality of life assessment

Estimated Enrollment:	1000
Study Start Date:	November 2006
Estimated Study Completion Date:	January 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420849

Locations

Australia
The Mater Private Centre for Haematology & Oncology
South Brisbane, Australia, QLD 4101
Austria, Montlearstrasse 37
Wilhelminenspital
Vienna, Montlearstrasse 37, Austria, 1160
Spain
H. Clínico de Salamanca
Salamanca, Spain
United Kingdom
Royal Free Hospital & Medical School
London, United Kingdom, NW3 2QG

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Robert Knight, MD

Celgene Therapeutic Area Head

More Information

No publications provided

Study ID Numbers:	CC-5013-MM-018
Study First Received:	January 9, 2007
Last Updated:	September 18, 2007
ClinicalTrials.gov Identifier:	NCT00420849 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Blood Protein Disorders
Hematologic Diseases
Hormone Antagonists
Blood Coagulation Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Lenalidomide
Vascular Diseases

Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Glucocorticoids
Multiple Myeloma
Hemorrhagic Disorders
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Immunoproliferative Disorders
Neoplasms by Histologic Type

Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Vascular Diseases
Lenalidomide
Gastrointestinal Agents
Glucocorticoids
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Autonomic Agents
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Central Nervous System Agents
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 09, 2009