NCT01863550

Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Active, enrolled Phase 3 Last updated 8 September 2025

What this trial tests

Phase 3 trial testing Bortezomib in Plasma Cell Myeloma in 1,087 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 December 2013

Primary endpoint
31 December 2026

5 February 2034

Quick facts

Lead sponsor	ECOG-ACRIN Cancer Research Group
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,087
Start date	6 December 2013
Primary completion	31 December 2026
Estimated completion	5 February 2034
Sites	920 locations across Puerto Rico, United States

Drugs / interventions tested

• Bortezomib (bortezomib) — full drug profile →
• Carfilzomib (carfilzomib) — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →
• Laboratory Biomarker Analysis
• Lenalidomide — full drug profile →
• Quality-of-Life Assessment

Conditions studied

• Plasma Cell Myeloma — all drugs for Plasma Cell Myeloma →

Sponsor

ECOG-ACRIN Cancer Research Group

Who can join

18 and older, any sex, with Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proteasome inhibitors in cancer therapy.
   Manasanch EE, Orlowski RZ. · · 2017 · cited 743× · PMID 28117417 · DOI 10.1038/nrclinonc.2016.206
2. Carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma without intention for immediate autologous stem-cell transplantation (ENDURANCE): a multicentre, open-label, phase 3, randomised, controlled trial.
   Kumar SK, Jacobus SJ, Cohen AD, Weiss M, et al · · 2020 · cited 182× · PMID 32866432 · DOI 10.1016/s1470-2045(20)30452-6
3. Multiple myeloma in the marrow: pathogenesis and treatments.
   Fairfield H, Falank C, Avery L, Reagan MR. · · 2016 · cited 128× · PMID 27002787 · DOI 10.1111/nyas.13038
4. Cancer therapies based on targeted protein degradation - lessons learned with lenalidomide.
   Jan M, Sperling AS, Ebert BL. · · 2021 · cited 111× · PMID 33654306 · DOI 10.1038/s41571-021-00479-z
5. Bortezomib for the Treatment of Hematologic Malignancies: 15 Years Later.
   Robak P, Robak T. · · 2019 · cited 103× · PMID 30993606 · DOI 10.1007/s40268-019-0269-9
6. Clinical use of proteasome inhibitors in the treatment of multiple myeloma.
   Merin NM, Kelly KR. · · 2014 · cited 66× · PMID 25545164 · DOI 10.3390/ph8010001
7. Emerging agents and regimens for multiple myeloma.
   Yang Y, Li Y, Gu H, Dong M, et al · · 2020 · cited 57× · PMID 33168044 · DOI 10.1186/s13045-020-00980-5
8. Minimal Residual Disease in Myeloma: Application for Clinical Care and New Drug Registration.
   Anderson KC, Auclair D, Adam SJ, Agarwal A, et al · · 2021 · cited 44× · PMID 34321279 · DOI 10.1158/1078-0432.ccr-21-1059