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

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

1. Andrzej J. Jakubowiak1,
2. Kent A. Griffith1,
3. Donna E. Reece2,
4. Craig C. Hofmeister3,
5. Sagar Lonial4,
6. Todd M. Zimmerman4,
7. Erica L. Campagnaro5,
8. Robert L. Schlossman6,
9. Jacob P. Laubach6,
10. Noopur S. Raje7,
11. Tara Anderson1,
12. Melissa A. Mietzel1,
13. Colleen K. Harvey1,
14. Sandra M. Wear8,
15. Jennifer C. Barrickman9,
16. Craig L. Tendler10,
17. Dixie-Lee Esseltine11,
18. Susan L. Kelley8,
19. Mark S. Kaminski1,
20. Kenneth C. Anderson6, and
21. Paul G. Richardson6

+ Author Affiliations

1. 1University of Michigan, Ann Arbor, MI;
2. 2Princess Margaret Hospital, Toronto, ON;
3. 3The Ohio State University, Columbus, OH;
4. 4University of Chicago, Chicago, IL;
5. 5University Hospital Case Medical Center, Cleveland, OH;
6. 6Dana-Farber Cancer Institute, Boston, MA;
7. 7Massachusetts General Hospital, Boston, MA;
8. 8Multiple Myeloma Research Consortium, Norwalk, CT;
9. 9Celgene Corporation, Summit, NJ;
10. 10Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ; and
11. 11Millennium Pharmaceuticals, The Takeda Oncology Company, Cambridge, MA


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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/m2, pegylated liposomal doxorubicin 30 mg/m2, 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.

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