Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma

Summary

This is a Phase 3 randomized trial of carfilzomib, lenalidomide, dexamethasone versus lenalidomide alone after stem-cell transplant for multiple myeloma, eligible to subjects who completed autologous stem cell transplant for symptomatic myeloma who are considered for lenalidomide maintenance.

Timeline

Start

2016-04-26

Primary completion

2027-11

Completion

2027-11

Outcome

Met primary endpoint

paper 4-year progression-free survival was 67·5% (95% CI 56·2-76·4) in the carfilzomib-lenalidomide-dexamethasone group and 38·0% (27·6-48·2) in the lenalidomide group (p<0·0001 PMID 41831471 ↗

paper hazard ratio 0·46 [95% CI 0·30-0·70]; log-rank p=0·0002 PMID 41831471 ↗

Publications

• Dytfeld D, Wrobel T, Jamroziak K, Kubicki T, Robak P, Pula A, Walter-Croneck A, Czyz J, Tyczynska A, Druzd-Sitek A, Giannopoulos K, Nowicki A, Szczepaniak T, Lojko-Dankowska A, Matuszak M, Gil L, Pula B, Rybka J, Majcherek M, Usnarska-Zubkiewicz L, Szukalski L, Konska A, Zaucha JM, Walewski J, Mikulski D, Czabak O, Robak T, Lahoud OB, Zonder JA, Cooperrider JH, Derman BA, Karrison T, Jakubowiak AJ. Carfilzomib, lenalidomide, and dexamethasone compared with lenalidomide treatment after autologous haematopoietic stem-cell transplantation in patients with multiple myeloma (ATLAS): primary analysis of a randomised, open-label, phase 3 trial. Lancet Haematol. 2026 Apr;13(4):e241-e253. doi: 10.1016/S2352-3026(26)00011-6. Epub 2026 Mar 11.
• Kubicki T, Jamroziak K, Robak P, Czyz J, Tyczynska A, Druzd-Sitek A, Giannopoulos K, Wrobel T, Nowicki A, Szczepaniak T, Lojko-Dankowska A, Matuszak M, Gil L, Pula B, Szukalski L, Konska A, Zaucha JM, Walewski J, Mikulski D, Czabak O, Robak T, Kruk-Kwapisz D, Derman BA, Major A, Jakubowiak AJ, Dytfeld D. Health-related quality of life in patients with multiple myeloma treated in the phase 3 ATLAS trial of post-transplant maintenance with carfilzomib, lenalidomide, and dexamethasone or lenalidomide alone. Pol Arch Intern Med. 2024 May 28;134(5):16749. doi: 10.20452/pamw.16749. Epub 2024 May 14. No abstract available.
• Kubicki T, Dytfeld D, Barnidge D, Sakrikar D, Przybylowicz-Chalecka A, Jamroziak K, Robak P, Czyz J, Tyczynska A, Druzd-Sitek A, Giannopoulos K, Wrobel T, Nowicki A, Szczepaniak T, Lojko-Dankowska A, Matuszak M, Gil L, Pula B, Szukalski L, Konska A, Zaucha JM, Walewski J, Mikulski D, Czabak O, Robak T, Jiang K, Cooperrider JH, Jakubowiak AJ, Derman BA. Mass spectrometry-based assessment of M protein in peripheral blood during maintenance therapy in multiple myeloma. Blood. 2024 Aug 29;144(9):955-963. doi: 10.1182/blood.2024024041.
• Dytfeld D, Wrobel T, Jamroziak K, Kubicki T, Robak P, Walter-Croneck A, Czyz J, Tyczynska A, Druzd-Sitek A, Giannopoulos K, Nowicki A, Szczepaniak T, Lojko-Dankowska A, Matuszak M, Gil L, Pula B, Rybka J, Majcherek M, Usnarska-Zubkiewicz L, Szukalski L, Konska A, Zaucha JM, Walewski J, Mikulski D, Czabak O, Robak T, Lahoud OB, Zonder JA, Griffith K, Stefka A, Major A, Derman BA, Jakubowiak AJ. Carfilzomib, lenalidomide, and dexamethasone or lenalidomide alone as maintenance therapy after autologous stem-cell transplantation in patients with multiple myeloma (ATLAS): interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023 Feb;24(2):139-150. doi: 10.1016/S1470-2045(22)00738-0. Epub 2023 Jan 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carfilzomib	Other / unclassified	36 mg/m2	Intravenous
Subject	Dexamethasone	Small molecule	20 mg	Oral
Comparator	Lenalidomide	Other / unclassified	15 mg	Oral
Comparator	Lenalidomide	Other / unclassified	25 mg	Oral

Indications