AR-42 in Treating Patients With Advanced or Relapsed Multiple Myeloma, Chronic Lymphocytic Leukem… (NCT01129193) | Clinical Trial Compass
CompletedPhase 1
AR-42 in Treating Patients With Advanced or Relapsed Multiple Myeloma, Chronic Lymphocytic Leukemia, or Lymphoma
United States44 participantsStarted 2010-05-04
Plain-language summary
RATIONALE: AR-42 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of AR-42 in treating patients with advanced or relapsed multiple myeloma, chronic lymphocytic leukemia, or lymphoma.
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 Hematologic Malignances Arm
* Patients must have CLL, prolymphocytic leukemia, or lymphoma (Hodgkins or Non-Hodgkins) as defined by 2008 WHO criteria or multiple myeloma as defined by IMWG criteria
* Patients must have received at least one prior antineoplastic therapy, must have progressed after at least 1 prior therapy, and for whom no standard therapy is available or whom decline such options; prior autologous and/or allogeneic transplant is permitted
* Prior biologic therapy or prior radiation is permitted; however, at least 28 days must have elapsed since the completion of prior therapy and patients must have recovered from all therapy-associated toxicities to no greater than grade 1 at the time of registration
* Patients with symptomatic disease may receive palliative corticosteroids up to 1 week before initiating therapy
* Patients must be off any prior chemotherapy for at least 28 days or 3 half lives, whichever is longer, and all therapy-related toxicity must have resolved to grade 1 or less
* ANC \>= 1000/uL
* Total bilirubin \< 1.5 mg/dL
* Serum creatinine =\< 1.5x institutional upper limit of normal or estimated creatinine clearance \>= 50 ml/min by MDRD (original or abbreviated), or measured creatinine clearance \>= 50 mL/min
* ECOG/WHO performance score of 0-1
* Patients must be able to swallow capsules
* Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
* Women with poten…
What they're measuring
1
Adverse events described using the NCI CTCAE criteria