Phase 1 study of elotuzumab (Elo) in combination with lenalidomide/dexamethasone (Len/dex) in Japanese patients (pts) with relapsed or refractory multiple myeloma (RRMM) and long-term follow-up

2015 ◽  
Vol 15 ◽  
pp. e162
Author(s):  
T. Chou ◽  
H. Nagai ◽  
G. Kinoshita ◽  
Y. Asaeda ◽  
E. Bleickardt ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Phase 1 ◽  
Japanese Patients ◽  
Phase 1 Study ◽  
Refractory Multiple Myeloma ◽  
Long Term Follow Up

Thalidomide Based Regimens (TBR) for Relapsed/Refractory Multiple Myeloma Patients: Long Term Follow Up, Unmaintained Remissions and Disease Control after Subsequent Treatments.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4812-4812
Author(s):  
Maria Roussou ◽  
Efstathios Kastritis ◽  
Athanasios Anagnostopoulos ◽  
Evangelos Eleftherakis-Papaiakovou ◽  
Charis Matsouka ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Progression Free Survival ◽  
Free Survival ◽  
Refractory Multiple Myeloma ◽  
Long Term Follow Up ◽  
Group A ◽  
Pulse Dexamethasone ◽  
Group B

Abstract Introduction: The effectiveness of thalidomide based regimens (TBR) in patients with relapsed/refractory multiple myeloma is well established. However, there are still limited data regarding the long term follow up after such regimens and the outcome of patients when they progress and they receive further treatment. In order to answer these questions we evaluated a series of 114 patients with relapsed/refractory multiple myeloma who were treated with TBR. None of these patients had previously received thalidomide, bortezomib or lenalidomide. Patients and Methods: All patients were treated with thalidomide and dexamethasone with or without other oral agents. More specifically 41 patients had received continuous thalidomide and pulse dexamethasone, 25 patients clarithromycin, continuous thalidomide and pulse dexamethasone, 43 patients intermittent thalidomide, pulse dexamethasone and cyclophosphamide and 5 patients continuous thalidomide, pulse dexamethasone and cyclophosphamide. Type of treatment at the time of progression after TBR, response to this treatment and progression free survival were recorded for each patient. Moreover, patients who received novel agents after progression to TBR, were divided into 2 subgroups, according to their resistance to thalidomide. In group A, patients had refractory or progressive myeloma while on TBR or within 2 months after discontinuation of TBR. In group B, myeloma progressed more than 2 months after discontinuation of TBR. Results: Among the 114 patients, 41 had not responded to TBR and 73 (64%) had achieved at least a partial response. The median PFS for all patients was 8 months. As of June 2007, 10 patients remain without progression from 28 to 81 months (median 54 months). Eight patients remain off treatment and without progression for a median of 56 months (range 28–81). Patients who did not respond to or progressed after TBR were analyzed for further treatment and outcome. Thirty eight patients (37%) died before receiving further treatment, 23 patients (23%) received conventional chemotherapy and 41 patients (40%) received continuous thalidomide and dexamethasone +/− clarithromycin or cyclophosphamide (17 patients), bortezomib and dexamethasone (7 patients), melphalan-bortezomib-dexamethasone and intermittent thalidomide (12 patients) or lenalidomide with dexamethasone (5 patients). Among these 41 patients, 24 were classified in group A (thalidomide resistant) and 17 in group B. Overall 17 (41%) achieved at least partial response after retreatment with novel agent-based regimens. A response was observed in 46% of patients in group A and in 35% of patients in group B. The median progression free survival of the 41 patients who received retreatment with novel agents was 9.2 months and the median survival was 17 months. Among the 23 patients who received conventional chemotherapy only five (21%) patients responded and the progression free survival and the median survival were 5.3 and 10.2 months, respectively. Conclusions: After an oral TBR regimen 6 (5%) patients remain without treatment and free of progression for more than 4 years. A significant number of patients who progressed after TBR and who received further treatment which included a novel agent achieved a response, including several patients who were resistant to TBR.

Phase 1 study of ixazomib alone or combined with lenalidomide-dexamethasone in Japanese patients with relapsed/refractory multiple myeloma

2016 ◽  
Vol 105 (4) ◽  
pp. 445-452 ◽  
Author(s):  
Kenshi Suzuki ◽  
Hiroshi Handa ◽  
Takaaki Chou ◽  
Kenichi Ishizawa ◽  
Takatoshi Takubo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Phase 1 ◽  
Japanese Patients ◽  
Phase 1 Study ◽  
Refractory Multiple Myeloma

Pomalidomide–dexamethasone in refractory multiple myeloma: long-term follow-up of a multi-cohort phase II clinical trial

Leukemia ◽  
2017 ◽  
Vol 32 (3) ◽  
pp. 719-728 ◽  
Author(s):  
S Ailawadhi ◽  
J R Mikhael ◽  
B R LaPlant ◽  
K M Laumann ◽  
S Kumar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Phase Ii ◽  
Phase Ii Clinical Trial ◽  
Refractory Multiple Myeloma ◽  
Long Term Follow Up

Didanosine: Long-Term Follow-Up of Patients in a Phase 1 Study

1993 ◽  
Vol 16 (Supplement_1) ◽  
pp. S40-S45 ◽  
Author(s):  
John S. Lambert ◽  
Mindell Seidlin ◽  
Fred T. Valentine ◽  
Richard C. Reichman ◽  
Raphael Dolin
Keyword(s):  
Phase 1 ◽  
Phase 1 Study ◽  
Long Term Follow Up

scholarly journals P.066 AVXS-101 gene-replacement therapy (GRT) in spinal muscular atrophy type 1 (SMA1): long-term follow-up from the phase 1 clinical trial

2019 ◽  
Vol 46 (s1) ◽  
pp. S32 ◽  
Author(s):  
JR Mendell ◽  
KJ Lehman ◽  
M McColly ◽  
LP Lowes ◽  
LN Alfano ◽  
...  
Keyword(s):  
Adverse Events ◽  
Physical Examination ◽  
Phase 1 ◽  
Developmental Milestones ◽  
Phase 1 Study ◽  
Dose Cohort ◽  
Follow Up Study ◽  
Long Term Follow Up

Background: SMA is a neurodegenerative disease caused by biallelic deletion/mutation of the survival motor neuron (SMN1) gene. In the phase 1 trial (NCT02122952), SMN GRT onasemnogene abeparvovec (AVXS-101) improved outcomes of 15 symptomatic SMA1 patients (3 at a lower dose [cohort 1] and 12 at the proposed therapeutic dose [cohort 2]). This report describes long-term follow-up study design and data from the phase 1 study. Methods: Patients in the phase 1 study could rollover into a long-term follow-up study (NCT03421977). The primary objective is to collect long-term safety data (serious adverse events, hospitalizations, and adverse events of special interest). Annual follow-up will occur for 15 years. Additionally, patient record transfers from local clinician(s) will be requested. Safety assessments include medical history and record review, physical examination, clinical laboratory evaluation, and pulmonary assessments. Efficacy assessments include physical examination to assess developmental milestones. Results: As of September 27, 2018, the oldest patients are 59.2 (cohort 1) and 52.1 (cohort 2) months old and free of permanent ventilation. Preliminary data, including survival and developmental milestones, will be presented. Conclusions: Patients treated with a one-time dose of AVXS-101 continue to gain strength, develop, and achieve new milestones, demonstrating a long-term, durable response.

Elotuzumab with lenalidomide and dexamethasone for Japanese patients with relapsed/refractory multiple myeloma: phase 1 study

2016 ◽  
Vol 105 (3) ◽  
pp. 326-334 ◽  
Author(s):  
Shinsuke Iida ◽  
Hirokazu Nagai ◽  
Gen Kinoshita ◽  
Masafumi Miyoshi ◽  
Michael Robbins ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Phase 1 ◽  
Japanese Patients ◽  
Phase 1 Study ◽  
Refractory Multiple Myeloma

Outcome of allogeneic transplantation in newly diagnosed and relapsed/refractory multiple myeloma: long-term follow-up in a single institution

2016 ◽  
Vol 97 (5) ◽  
pp. 479-488 ◽  
Author(s):  
Laurens E. Franssen ◽  
Reinier A. P. Raymakers ◽  
Arjan Buijs ◽  
Marian F. Schmitz ◽  
Suzanne van Dorp ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Allogeneic Transplantation ◽  
Newly Diagnosed ◽  
Single Institution ◽  
Refractory Multiple Myeloma ◽  
Long Term Follow Up
Sign in / Sign up

Export Citation Format

Share Document