Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Steven P. Treon, MD, PhD
Study ID
NCT01078974
Phase
PHASE1
Status
Terminated

Conditions

  • Waldenstrom's Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pomalidomide — DRUG
    Taken orally once a day
  • dexamethasone — DRUG
    Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
  • rituximab — DRUG
    Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

Study Details

Pomalidomide is a newly discovered drug that may stop cancer cells from growing abnormally. Pomalidomide may also stimulate the immune system to fight the cancer cells and possibly improve the effectiveness of dexamethasone and rituximab to fight the Waldenstrom's Macroglobulinemia (WM) cancer cells. This drug have been used in multiple myeloma and information from these other research studies suggests that Pomalidomide may help to reduce or prevent the growth of cancer cells.

Key Dates

Start date
May 31, 2010
Status verified
Jun 2016
Primary completion
Sep 30, 2015
Completion
Mar 31, 2016

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: pomalidomide, dexamethasone, rituximab
    Drug: pomalidomide Taken orally once a day Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15 Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

Primary Outcome Measure

Maximum Tolerated Dose of Pomalidomide [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MA