Bruton's Tryosine Kinase (Btk) Inhibitor, PCI-32765, in Subjects with Relapsed or Relapsed and Refractory Multiple Myeloma
Phase: Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01478581
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-059
The primary objective of this study is to determine the efficacy of PCI-32765, both as a single agent and in combination with dexamethasone, in subjects with relapsed or relapsed and refractory Multiple Myeloma (MM)
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center
Paul Richardson, MD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
Kathleen Colson, 617-632-6303,
- Men and women ≥18 years of age.
- Karnofsky Performance Status (KPS) of ≥70%.
- Life expectancy of ≥12 weeks.
- Diagnosis of symptomatic MM with measurable disease, defined here as having at least
one of the following:
1. Serum monoclonal protein (M-protein) ≥0.5 g/dL as determined by serum protein
2. Urine M-protein ≥200 mg/24 hrs
3. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L)
provided serum FLC ratio is abnormal
- Relapsed or relapsed and refractory MM after receiving at least 2 previous lines of
therapy, 1 of which must be an immunomodulator. Relapsed myeloma is defined as the
occurrence of any of the following after most recent treatment:
1. >25% increase in M-protein from the baseline levels;
2. reappearance of the M-protein that had become undetectable; or
3. increase in the size and number of lytic bone lesions recognized on radiographs
(compression fractures per se do not constitute a relapse). Refractory myeloma
(to most recent treatment) is defined as ≤25% response or progression during
treatment or within 60 days after the completion of preceding treatment.
- Polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS)
syndrome, osteosclerotic myeloma, or Crow-Fukase syndrome.
- Plasma cell leukemia.
- Primary amyloidosis.
- Certain restrictions on prior treatments may apply.
- ANC <0.75 x 10^9/L independent of Granulocyte colony-stimulating factor.
- Platelets <50 x 10^9/L) independent of transfusion support.
- AST or ALT ≥3.0 x upper limit of normal (ULN).
- Total bilirubin >2.5 x ULN, unless due to Gilbert's syndrome.
- Creatinine >2.5 mg/dL.
- PT, INR, or aPTT >ULN.
- Concomitant therapy with denosumab (bisphosphonate is allowed).
- The subject has uncontrolled, significant intercurrent illness.
- QTc >470 msec.
- Unable to swallow capsules or disease significantly affecting gastrointestinal
function, such as malabsorption syndrome, resection of the stomach or small bowel, or
complete bowel obstruction.
- Peripheral neuropathy Grade ≥2 on clinical examination within 14 days prior to