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Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia

Primary Purpose

Waldenstrom's Macroglobulinemia

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

pomalidomide

dexamethasone

rituximab

About this trial

This is an interventional treatment trial for Waldenstrom's Macroglobulinemia focused on measuring WM, pomalidomide, dexamethasone, rituximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pomalidomide, dexamethasone, rituximab

Arm 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

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose of Pomalidomide

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.

Tolerability of Pomalidomide

Number of participants with dose limiting toxicities which resulted in being removed from pomalidomide therapy

Secondary Outcome Measures

Full Information

NCT ID

NCT01078974

First Posted

March 1, 2010

Last Updated

June 13, 2016

Sponsor

Steven P. Treon, MD, PhD

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01078974

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Terminated

Why Stopped

Safety concerns (IgM Flare)

Study Start Date

May 2010 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Steven P. Treon, MD, PhD

Collaborators

Celgene Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Waldenstrom's Macroglobulinemia

Keywords

WM, pomalidomide, dexamethasone, rituximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pomalidomide, dexamethasone, rituximab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

pomalidomide

Other Intervention Name(s)

CC-4047, Pomalyst

Intervention Description

Taken orally once a day

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Other Intervention Name(s)

Decadron

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

rituximab

Other Intervention Name(s)

Rituxan

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose of Pomalidomide

Description

Time Frame

2 years

Title

Tolerability of Pomalidomide

Description

Number of participants with dose limiting toxicities which resulted in being removed from pomalidomide therapy

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven P. Treon, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia

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