Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2011 Jul 21;118(3):535-43.
doi: 10.1182/blood-2011-02-334755. Epub 2011 May 19.

Lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone in newly diagnosed multiple myeloma: a phase 1/2 Multiple Myeloma Research Consortium trial

Andrzej J Jakubowiak  1 , Kent A Griffith, Donna E Reece, Craig C Hofmeister, Sagar Lonial, Todd M Zimmerman, Erica L Campagnaro, Robert L Schlossman, Jacob P Laubach, Noopur S Raje, Tara Anderson, Melissa A Mietzel, Colleen K Harvey, Sandra M Wear, Jennifer C Barrickman, Craig L Tendler, Dixie-Lee Esseltine, Susan L Kelley, Mark S Kaminski, Kenneth C Anderson, Paul G Richardson
Affiliations
Clinical Trial

Lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone in newly diagnosed multiple myeloma: a phase 1/2 Multiple Myeloma Research Consortium trial

Andrzej J Jakubowiak et al. Blood. .

Abstract

This phase 1/2 trial evaluated combination lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone (RVDD) in newly diagnosed multiple myeloma (MM) patients. Patients received RVDD at 4 dose levels, including the maximum tolerated dose (MTD). Patients with a very good partial response or better (≥ VGPR) after cycle 4 proceeded to autologous stem cell transplantation or continued treatment. The primary objectives were MTD evaluation and response to RVDD after 4 and 8 cycles. Seventy-two patients received a median of 4.5 cycles. The MTDs were lenalidomide 25 mg, bortezomib 1.3 mg/m(2), pegylated liposomal doxorubicin 30 mg/m(2), and dexamethasone 20/10 mg, as established with 3-week cycles. The most common adverse events were fatigue, constipation, sensory neuropathy, and infection; there was no treatment-related mortality. Response rates after 4 and 8 cycles were 96% and 95% partial response or better, 57% and 65% ≥ VGPR, and 29% and 35% complete or near-complete response, respectively. After a median follow-up of 15.5 months, median progression-free survival (PFS) and overall survival (OS) were not reached. The estimated 18-month PFS and OS were 80.8% and 98.6%, respectively. RVDD was generally well tolerated and highly active, warranting further study in newly diagnosed MM patients. This trial was registered at www.clinicaltrials.gov as NCT00724568.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials (CONSORT) diagram.
Figure 2
Figure 2
Response rates in the non-ASCT and ASCT groups of patients. For simplicity, CR and nCR rates were combined. In the non-ASCT group, the CR rate was 8.6% and at best response 26%, including 4% sCR, at 4 cycles. In the ASCT group, the CR rate was 22% and after ASCT 37%, including 22% sCR, at 4 cycles.
Figure 3
Figure 3
Kaplan-Meier survival estimates. Shown are estimates for OS and PFS among all patients treated with RVDD (A) and PFS among patients who did or did not go on to transplantation (B).
See this image and copyright information in PMC

References

    1. Harousseau JL, Avet-Loiseau H, Attal M, et al. Achievement of at least very good partial response is a simple and robust prognostic factor in patients with multiple myeloma treated with high-dose therapy: long-term analysis of the IFM 99-02 and 99-04 trials. J Clin Oncol. 2009;27(34):5720–5726. - PubMed
    1. Harousseau JL, Palumbo A, Richardson PG, et al. Superior outcomes associated with complete response in newly diagnosed multiple myeloma patients treated with non-intensive therapy: analysis of the phase 3 VIST.A. study of bortezomib plus melphalan-prednisone versus melphalan-prednisone. Blood. 2010;116(19):3743–3750. - PubMed
    1. Niesvizky R, Richardson PG, Rajkumar SV, et al. The relationship between quality of response and clinical benefit for patients treated on the bortezomib arm of the international, randomized, phase 3 APEX trial in relapsed multiple myeloma. Br J Haematol. 2008;143(1):46–53. - PubMed
    1. Jakubowiak AJ, Kendall T, Al-Zoubi A, et al. Phase II trial of combination therapy with bortezomib, pegylated liposomal doxorubicin, and dexamethasone in patients with newly diagnosed myeloma. J Clin Oncol. 2009;27(30):5015–5022. - PubMed
    1. Cavo M, Tacchetti P, Patriarca F, et al. Bortezomib with thalidomide plus dexamethasone compared with thalidomide plus dexamethasone as induction therapy before, and consolidation therapy after, double autologous stem-cell transplantation in newly diagnosed multiple myeloma: a randomised phase 3 study. Lancet. 2010;376(9758):2075–2085. - PubMed

Publication types

MeSH terms

Associated data