scholarly journals Phase 2 trial of the histone deacetylase inhibitor romidepsin for the treatment of refractory multiple myeloma

Cancer ◽  
2010 ◽  
Vol 117 (2) ◽  
pp. 336-342 ◽  
Author(s):  
Ruben Niesvizky ◽  
Scott Ely ◽  
Tomer Mark ◽  
Sangeeta Aggarwal ◽  
Janice L Gabrilove ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Histone Deacetylase ◽  
Histone Deacetylase Inhibitor ◽  
Phase 2 ◽  
Refractory Multiple Myeloma ◽  
Phase 2 Trial ◽  
Deacetylase Inhibitor

scholarly journals Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma

Blood ◽  
2011 ◽  
Vol 117 (22) ◽  
pp. 5827-5834 ◽  
Author(s):  
Richard L. Piekarz ◽  
Robin Frye ◽  
H. Miles Prince ◽  
Mark H. Kirschbaum ◽  
Jasmine Zain ◽  
...  
Keyword(s):  
Stem Cell ◽  
T Cell ◽  
Histone Deacetylase Inhibitor ◽  
Stem Cell Transplant ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Cell Transplant ◽  
Phase 2 ◽  
Phase 2 Trial ◽  
Deacetylase Inhibitor

Abstract Romidepsin (depsipeptide or FK228) is a histone deacetylase inhibitor, one of a new class of agents active in T-cell lymphoma. A phase 2 trial was conducted in cutaneous (CTCL) and peripheral (PTCL) T-cell lymphoma. Major and durable responses in CTCL supported the approval of romidepsin for CTCL. Forty-seven patients with PTCL of various subtypes including PTCL NOS, angioimmunoblastic, ALK-negative anaplastic large cell lymphoma, and enteropathy-associated T-cell lymphoma were enrolled. All patients had received prior therapy with a median of 3 previous treatments (range 1-11); 18 (38%) had undergone stem-cell transplant. All patients were evaluated for toxicity; 2 patients discovered to be ineligible were excluded from response assessment. Common toxicities were nausea, fatigue, and transient thrombocytopenia and granulocytopenia. Complete responses were observed in 8 and partial responses in 9 of 45 patients, for an overall response rate of 38% (95% confidence interval 24%-53%). The median duration of overall response was 8.9 months (range 2-74). Responses were observed in various subtypes, with 6 responses among the 18 patients with prior stem-cell transplant. The histone deacetylase inhibitor romidepsin has single agent clinical activity associated with durable responses in patients with relapsed PTCL. This study has been registered at clinicaltrials.gov as NCT00007345.

scholarly journals Ibrutinib alone or with dexamethasone for relapsed or relapsed and refractory multiple myeloma: phase 2 trial results

2018 ◽  
Vol 180 (6) ◽  
pp. 821-830 ◽  
Author(s):  
Paul G. Richardson ◽  
William I. Bensinger ◽  
Carol Ann Huff ◽  
Caitlin L. Costello ◽  
Nikoletta Lendvai ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Phase 2 ◽  
Refractory Multiple Myeloma ◽  
Phase 2 Trial

Analysis of efficacy and safety of POM as a replacement therapy for lenalidomide for relapsed/refractory multiple myeloma pts refractory to a lenalidomide-containing combination regimen.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e19528-e19528
Author(s):  
James R. Berenson ◽  
Alexa Cohen ◽  
Tanya M. Spektor ◽  
Ashkan Lashkari ◽  
Roy Mackintosh ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Replacement Therapy ◽  
Randomized Study ◽  
Combination Regimen ◽  
Phase 2 ◽  
Open Label ◽  
Refractory Multiple Myeloma ◽  
Phase 2 Trial ◽  
Previous Regimen

e19528 Background: Pomalidomide (POM) is a third –generation immunomodulatory drug shown to be safe and effective for the treatment of relapsed/refractory multiple myeloma (RRMM) for patients (pts) previously treated with bortezomib and lenalidomide (LEN) and in combination with dexamethasone it has been shown to overcome resistance in RRMM. In this phase 2 trial, we are evaluating the efficacy, safety and tolerability of POM as a replacement therapy for LEN for pts who have progressed receiving a LEN combination regimen. Methods: This is a phase 2, multicenter, open-label and non-randomized study. Pts who have failed a combination regimen containing LEN were treated with POM along with all of the other drugs previously used in the regimen. POM administered orally (dose is determined based on the previous regimen) on days 1-21 of a 28-day cycle, whereas other drugs are administered using the same schedule(s), dose(s) and drug combination as the last LEN-containing regimen that the patient received and failed. The planned enrollment on the study will be 45 pts. Results: To date, a total of 29 pts have been enrolled, 25 pts are evaluable and 12 pts have discontinued treatment. Of the evaluable pts, 9 (36%) and 16 (64%) received 3mg and 4mg of POM, respectively. The median age of all pts was 72 years (range, 52-81), and 17 (68%) were males. Pts have received a median of 3 prior treatments (range, 1-7). The median follow-up time for all pts is 3.1 months (range, 0.2-8.1). Amongst evaluable pts, 5 (23.8%) pts achieved at least a minimal response, 10 (47.6%) pts showed stable disease while 6 (28.6%) pts exhibited disease progression. At the time of data cutoff, only 17 pts have completed more than 1 full cycle of treatment; and, thus, the overall response and clinical benefit rates are fairly low (14.3% and 23.8%, respectively) but expected to improve with further follow up. The median PFS for the cohort was 7.6 months. Common ≥ Gr3 adverse events were neutropenia (8%), hypomania (4%) and leukopenia (4%). Conclusions: We show thatPOM appears to be promising replacement therapy for LEN in RRMM pts who have progressed within receiving a LEN combination regimen.

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