Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (NCT01198067) | Clinical Trial Compass
TerminatedPhase 1
Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia
Stopped: \<75% participant accrual
United States15 participantsStarted 2010-10-06
Plain-language summary
This phase I trial studies the side effects and best dose of pomalidomide in treating patients with Waldenstrom macroglobulinemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Pomalidomide may stimulate the immune system in different ways and stop cancer cells from growing.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Understand and voluntarily sign an informed consent form
* Able to adhere to the study visit schedule and other protocol requirements
* Waldenstrom'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
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 at study entry
* 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
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 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 additio…
What they're measuring
1
Number of Patients Experiencing MTD
Timeframe: Participants Experiencing Study Medication Maximum Tolerated Dose through Study Completion (Avg. 1 Year)