Search

Your search keyword '"MM-003"' showing total 2 results
Start Over Descriptor "MM-003"
2 results on '"MM-003"'

1. Relationship of response and survival in patients with relapsed and refractory multiple myeloma treated with pomalidomide plus low-dose dexamethasone in the MM-003 trial randomized phase III trial (NIMBUS).

Author

Moreau, Philippe, Weisel, Katja C., Song, Kevin W., Gibson, Craig J., Saunders, Owain, Sternas, Lars Axel, Hong, Kevin, Zaki, Mohamed H., and Dimopoulos, Meletios A.

Subjects
*MULTIPLE myeloma, *DEXAMETHASONE, *DISEASE progression, *CLINICAL trials, *CANCER relapse, *BORTEZOMIB, *PATIENTS
Abstract

Relapsed/refractory multiple myeloma (RRMM) patients have poor overall survival (OS). Pomalidomide plus low-dose dexamethasone (POM + LoDEX) significantly extends OS in RRMM vs. high-dose dexamethasone. Survival of patients with stable disease (SD) was compared to patients with progressive disease (PD) or ≥ partial response (≥PR) at cycles (C) 3, 5, and 7. Among 302 patients randomized to POM + LoDEX, at C3 19.2% achieved ≥ PR, 38.4% SD, and 14.6% PD. Patients with SD at C3 (17.4%) and C5 (13.6%) showed improved responses at C7. Median OS from randomization by response at C3 was 22.4 months for ≥ PR (n = 58, HR 0.66; 95% CI 0.40–1.08,p = 0.0976 vs. SD), 16.2 months for SD (n = 116), and 6.3 months for PD (n = 44, HR 3.43; 95% CI 2.23–5.27,p < 0.0001 vs. SD). Similar patterns were observed for C5 and C7. Results show that POM + LoDEX should be a standard treatment after lenalidomide and bortezomib, including in SD patients. [ABSTRACT FROM AUTHOR]

Published
2016
Full Text
View/download PDF

2. Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma

Author

San Miguel, Jesús F., Weisel, Katja C., Song, Kevin W., Delforge, Michel, Karlin, Lionel, Goldschmidt, Hartmut, Moreau, Philippe, Banos, Anne, Oriol, Albert, Garderet, Laurent, Cavo, Michele, Ivanova, Valentina, Alegre, Adrián, Martínez-López, Joaquín, Chen, Chritine, Renner, Christoph, Bahlis, Nizar Jacques, Yu, Xin, Teasdale, Terri, Sternas, Lars, Jacques, Christian, Zaki, Mohamed H., Dimopoulos, Meletios A., UAM. Departamento de Medicina, Instituto de Investigación del Hospital de La Princesa (IP), San Miguel, Jesus F, Weisel, Katja C, Song, Kevin W, Delforge, Michel, Karlin, Lionel, Goldschmidt, Hartmut, Moreau, Philippe, Banos, Anne, Oriol, Albert, Garderet, Laurent, Cavo, Michele, Ivanova, Valentina, Alegre, Adrian, Martinez-Lopez, Joaquin, Chen, Christine, Renner, Christoph, Bahlis, Nizar Jacque, Yu, Xin, Teasdale, Terri, Sternas, Lar, Jacques, Christian, Zaki, Mohamed H, and Dimopoulos, Meletios A

Subjects
Oncology, Male, medicine.medical_specialty, MM-003, Medicina, Pharmacology, Dexamethasone, Recurrence, Multiple myeloma, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Survival analysis, Lenalidomide, Aged, Aged, 80 and over, Bortezomib, business.industry, MM, Pomalidomide, pomalidomide + low-dose dexamethasone, high-dose dexamethasone, Hematology, Articles, Pomalidomide, medicine.disease, Survival Analysis, Thalidomide, Treatment, Treatment Outcome, Tolerability, Retreatment, Female, business, Multiple Myeloma, medicine.drug, Follow-Up Studies
Abstract

Pomalidomide is a distinct oral IMiD immunomodulatory agent with direct antimyeloma, stromal-support inhibitory, and immunomodulatory effects. The pivotal, multicenter, open-label, randomized phase 3 trial MM-003 compared pomalidomide + low-dose dexamethasone vs high-dose dexamethasone in 455 patients with refractory or relapsed and refractory multiple myeloma after failure of bortezomib and lenalidomide treatment. Initial results demonstrated significantly longer progression-free survival and overall survival with an acceptable tolerability profile for pomalidomide + low-dose dexamethasone vs high-dose dexamethasone. This secondary analysis describes patient outcomes by treatment history and depth of response. Pomalidomide + low-dose dexamethasone significantly prolonged progression-free survival and favored overall survival vs high-dose dexamethasone for all subgroups analyzed, regardless of prior treatments or refractory status. Both univariate and multivariate analyses showed that no variable relating to either the number (≤ or > 3) or type of prior treatment was a significant predictor of progression-free survival or overall survival. No cross-resistance with prior lenalidomide or thalidomide treatment was observed. Patients achieving a minimal response or better to pomalidomide + low-dose dexamethasone treatment experienced a survival benefit, which was even higher in those achieving at least a partial response (17.2 and 19.9 months, respectively, as compared with 7.5 months for patients with less than minimal response). These data suggest that pomalidomide + low-dose dexamethasone should be considered a standard of care in patients with refractory or relapsed and refractory multiple myeloma regardless of prior treatment. ClinicalTrials.gov: NCT01311687; EudraCT: 2010-019820-30. ispartof: Haematologica vol:100 issue:10 pages:1334-9 ispartof: location:Italy status: published

Published
2015

Catalog

Books, media, physical & digital resources
See catalog results