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A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma

A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00051116
Enrollment
100
Registered
2003-01-07
Start date
2002-05-31
Completion date
2006-10-31
Last updated
2009-09-23

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Revimid, CC5013, CC-5013

Brief summary

To evaluate the response rate, response duration, and survival of patients treated with CC-5013 in a chronic dosing schedule versus a syncopated dosing schedule.

Interventions

Sponsors

Celgene Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* History of histologically documented multiple myeloma with relapsed or resistant disease * Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. * Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations

Countries

United States

Outcome results

None listed

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