Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2, or IFN Based Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00057616

Enrollment

274

Registered

2003-04-07

Start date

2002-10-01

Completion date

2005-07-15

Last updated

2019-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma, Neoplasm Metastasis

Keywords

Metastatic Melanoma, Melanoma, Revimid, CC5013

Brief summary

Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects are treated in repeating 4 week cycles.

Interventions

DRUGCC-5013

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Understand and voluntarily sign an informed consent form * Able to adhere to the study visit schedule and other protocol requirements * Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy * Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug * Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.

Countries

Australia, Estonia, Germany, Latvia, Lithuania, Netherlands, South Africa, Ukraine, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026