Pomalidomide, Dexamethasone and Rituximab in Waldenstrom’s Macroglobulinemia

Brief Title

Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia

Official Title

Phase I Study of Pomalidomide, Dexamethasone and Rituximab (PDR) in Relapsed or Refractory Waldenstrom's Macroglobulinemia

Brief Summary

      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.
    

Detailed Description

      -  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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Maximum Tolerated Dose of Pomalidomide

Condition

Waldenstrom's Macroglobulinemia

Intervention

pomalidomide

Study Arms / Comparison Groups

 pomalidomide, dexamethasone, rituximab

Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

7

Start Date

May 2010

Completion Date

March 2016

Primary Completion Date

September 2015

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Steven P. Treon, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01078974

Organization ID

10-007

Secondary IDs

PO-WM-PI-0005

Responsible Party

Sponsor-Investigator

Study Sponsor

Steven P. Treon, MD, PhD

Collaborators

 Celgene Corporation

Study Sponsor

Steven P. Treon, MD, Principal Investigator, Dana-Farber Cancer Institute

Verification Date

June 2016