Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia

June 13, 2016 updated by: Steven P. Treon, MD, PhD

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: pomalidomide
Taken orally once a day
Other Names:
  • Pomalyst
  • CC-4047
Drug: dexamethasone
Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
Other Names:
  • Decadron
Drug: rituximab
Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
Other Names:
  • Rituxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose of Pomalidomide
Time Frame: 2 years
To determine the MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab. Because maximum tolerated dose was not determined due to study termination, the highest dose of pomalidomide administered is presented below.
2 years
Tolerability of Pomalidomide
Time Frame: 2 years
Number of participants with dose limiting toxicities which resulted in being removed from pomalidomide therapy
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steven P. Treon, MD, PhD

Collaborators

Celgene Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (ESTIMATE)

March 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-007
  • PO-WM-PI-0005 (OTHER: Celgene)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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