Pomalidomide for Relapse/Refractory Waldenstrom's
This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01198067
First received: September 8, 2010
Last updated: April 16, 2013
Last verified: April 2013
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Purpose
The goal of this clinical research study is to find the highest tolerable dose of pomalidomide that can be given to patients with relapsed or refractory WM. The safety of this drug will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Myeloma |
Drug: Pomalidomide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Pomalidomide in Relapsed or Refractory Waldenstrom Macroglobulinemia |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]MTD is defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT) defined as any grade >/= 3 toxicity occurring during the first cycle (28 days).
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pomalidomide Schedule A
Starting dose 1 mg orally for 28 days
|
Drug: Pomalidomide
Starting dose level 1 mg by mouth on days 1-28 of a 28 day cycle.
Other Names:
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Experimental: Pomalidomide Schedule B
Starting dose level 1 mg orally for 21 days then 7 days rest
|
Drug: Pomalidomide
Starting dose level 1 mg by mouth on days 1-21 of a 28 day cycle.
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Understand and voluntarily sign an informed consent form
- Age >/= 18 years at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Waldenström's Macroglobulinemia that has relapsed and/or is refractory to at least one prior line of therapy
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
- ECOG performance status of </= 2 at study entry
- Laboratory test results within these ranges: Serum creatinine </= 2.0 mg/dL; Creatinine clearance >/= 45 ml/min; Total bilirubin </= 3 x Upper Limit of Normal (ULN) or Direct Bilirubin </= 2 x ULN; AST (SGOT) and ALT (SGPT) </= 2 x ULN; Platelet count >/= 20 K/microL; Absolute neutrophil count >/= 500 K/microL
- Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 to 14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide
- Continued from Inclusion #9: FCBP must also agree to ongoing pregnancy testing. Men must agree to practice complete abstinence or agree use a latex condom during sexual contact with a FCBP while participating in the study, during dose interruptions and for at least 90 days following study drug discontinuation, even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
- Able to take aspirin (325mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use therapeutic dose warfarin or low molecular weight heparin).
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking pomalidomide or for 28 days after stopping pomalidomide)
- Any medical or psychiatric 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
- Use of any other experimental drug or therapy within 28 days of the first dose of study drug
- Known hypersensitivity to thalidomide or lenalidomide
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- Any prior use of pomalidomide
- Concurrent use of other anti-cancer agents or treatments
- Known positive for HIV or acute hepatitis A or acute or chronic active hepatitis B or C
- Grade >2 peripheral neuropathy
- Neutrophil count <1000K/microL and/or platelet count <100K/microL unless infiltration by Waldenström's Macroglobulinemia equals or exceed 60% of bone marrow cellularity.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198067
Contacts
| Contact: Sheeba K. Thomas, MD | 713-792-2860 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Sheeba K. Thomas, MD 713-792-2860 | |
| Principal Investigator: Sheeba K. Thomas, MD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
| Principal Investigator: | Sheeba K. Thomas, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01198067 History of Changes |
| Other Study ID Numbers: | 2009-0972 |
| Study First Received: | September 8, 2010 |
| Last Updated: | April 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Waldenstrom Macroglobulinemia B-cell lymphoproliferative disorder Bone marrow Lymphoplasmacytic cells |
Monoclonal gammopathy Pomalidomide Actimid CC-4047 |
Additional relevant MeSH terms:
|
Lymphoma Waldenstrom Macroglobulinemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013