CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia

Conditions

• Waldenstrom's Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• CC-5103 (lenalidomide) — DRUG
  Taken orally once a day for 21 days followed by 7 days of no CC-5103 (lenalidomide)
• Rituximab — DRUG
  Begins on week 2 of treatment and is given intravenously once a week for 4 weeks

Study Details

The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab, what the side effects are and how long the benefit will last.

Key Dates

Start date

Sep 30, 2004

Status verified

Mar 2016

Primary completion

May 31, 2006

Completion

Apr 30, 2008

Study Design

Enrollment

16 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: CC-5103 (Lenalidomide) and Rituximab
  Intended therapy consisted of 48 weeks of CC-5103 (lenalidomide)(25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.

Primary Outcome Measure

Time to Progression [ Time Frame: 34.3 months ]

Locations (2)

Find similar trials in Boston, MA