Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia

NCT ID: NCT01078974

Last Updated: 2016-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2016-03-31

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.

Conditions

Waldenstrom's Macroglobulinemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

pomalidomide

Intervention Type: DRUG

Taken orally once a day

dexamethasone

Intervention Type: DRUG

Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

rituximab

Intervention Type: DRUG

Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

Interventions

pomalidomide

Taken orally once a day

Intervention Type: DRUG

dexamethasone

Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

Intervention Type: DRUG

rituximab

Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

Intervention Type: DRUG

Other Intervention Names

CC-4047; Pomalyst; Decadron; Rituxan

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Steven P. Treon, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Steven P. Treon, MD, PhD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steven P. Treon, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

PO-WM-PI-0005

Identifier Type: OTHER

Identifier Source: secondary_id

10-007

Identifier Type: -

Identifier Source: org_study_id