Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Steven P. Treon, MD, PhD, Dana-Farber/Brigham and Women's Cancer Center
ClinicalTrials.gov Identifier:
NCT01078974
First received: March 1, 2010
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Waldenstrom's Macroglobulinemia
Drug: pomalidomide
Drug: dexamethasone
Drug: rituximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Pomalidomide, Dexamethasone and Rituximab (PDR) in Relapsed or Refractory Waldenstrom's Macroglobulinemia

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Safety Profile, Tolerability and Maximum Tolerated Dose [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To determine the safety profile, tolerability, and MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab


Estimated Enrollment: 24
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • CC-4047
  • Pomalyst
Drug: dexamethasone
Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
Other Name: Decadron
Drug: rituximab
Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
Other Name: Rituxan

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078974

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Steven P. Treon, MD, PhD
Celgene Corporation
Investigators
Principal Investigator: Steven P. Treon, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Steven P. Treon, MD, PhD, Principal Investigator, Dana-Farber/Brigham and Women's Cancer Center
ClinicalTrials.gov Identifier: NCT01078974     History of Changes
Other Study ID Numbers: 10-007, PO-WM-PI-0005
Study First Received: March 1, 2010
Last Updated: June 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
WM
pomalidomide
dexamethasone
rituximab

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Rituximab
Pomalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014