Phase I Study of Pomalidomide, Dexamethasone and Rituximab (PDR) in Relapsed or Refractory Waldenstrom's Macroglobulinemia
18 Years
N/A
Both
Waldenstrom's Macroglobulinemia
Trial Information
Phase I Study of Pomalidomide, Dexamethasone and Rituximab (PDR) in Relapsed or Refractory Waldenstrom's Macroglobulinemia
- Participants will be given a study drug-dosing calendar for each treatment cycle. Each
treatment cycle lasts 28 days during which time participants will take Pomalidomide
orally once a day. Dexamethasone and rituximab will be administered intravenously on
weeks 1, 2, 3, 4 and on weeks 12, 13, 14, 15.
- Since we are looking for the highest dose of Pomalidomide in combination with
dexamethasone and rituximab which can be administered safely without severe or
unmanageable side effects, not everyone who participates will receive the same dose of
the study drug. The dose participants will get will depend on the number of
participants who have been enrolled in the study and how well they have tolerated their
doses.
- As long as there is no evidence that the participant's Waldenstrom's Macroglobulinemia
has progressed, they can continue to receive Pomalidomide for up to 52 weeks.
Participants will be asked to return to the clinic for follow-up tests at least every
three months for four years.
Inclusion Criteria:
- 18 years of age or older
- Able to adhere to the study visit schedule and other protocol requirements
- Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus
panel criteria
- CD20 positive based on any previous performed bone marrow immunohistochemistry or
flow cytometric analysis
- Meet criteria to treat based on consensus panel criteria
- Patient must have received at least one previous therapy for WM
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must
have been discontinued at least 4 weeks prior to treatment in this study
- Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a
minimum IgM level of 2 times (or greater) the upper limit of each institution's
normal value is required
- ECOG Performance status of 0, 1 or 2
- Laboratory tests within ranges outlined in the protocol
- Disease free of prior malignancies for 5 years or more with exception of currently
treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the
cervix or breast
- Screening of patients at high risk of HBV or HCV infection
- Willing and able to take aspirin or alternate prophylactic anticoagulants
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric illness
- Pregnant or lactating females
- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study
- Resistance or intolerance to prior rituximab therapy
- Previous therapy with thalidomide or lenalidomide
- Known hypersensitivity to thalidomide, lenalidomide or pomalidomide
- The development of erythema nodosum if characterized by a desquamating rash while
taking similar drugs
- Concurrent use of other anti-cancer agents or treatments
- History of non-compliance to medical regimens
- Patients unwilling to or unable to comply with the protocol
- Known positive for HIV or hepatitis infection
- Any history of CVA (Cerebral Vascular Accident/stroke) or clots
- Active DVT or PE that has not been therapeutically anticoagulated
- NYHA classification III and greater heart failure
- Any patient that is unable to ingest or process pomalidomide
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety Profile, Tolerability and Maximum Tolerated Dose
Outcome Description:
To determine the safety profile, tolerability, and MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Steven P. Treon, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
10-007
NCT ID:
NCT01078974
Start Date:
May 2010
Completion Date:
August 2013
Related Keywords:
- Waldenstrom's Macroglobulinemia
- WM
- pomalidomide
- dexamethasone
- rituximab
- Waldenstrom Macroglobulinemia
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
