Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia
This study is ongoing, but not recruiting participants.
Sponsor:
Steven P. Treon, MD, PhD
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01078974
First received: March 1, 2010
Last updated: June 7, 2012
Last verified: June 2012
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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:
MedlinePlus related topics:
Cancer
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Pomalidomide
Rituximab
U.S. FDA Resources
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: | August 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed 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
- 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
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, Director of the Bing Center for Waldenström's Macroglobulinemia, Dana-Farber Cancer Institute |
| 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 7, 2012 |
| 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 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 Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013