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


Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

up to 123 weeks

Safety Issue:

Yes

Principal Investigator

Robert Knight, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Therapeutic Area Head

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CC-5013-MM-018

NCT ID:

NCT00420849

Start Date:

November 2006

Completion Date:

November 2009

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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