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Clinical Trial
. 2015 Sep 10;126(11):1294-301.
doi: 10.1182/blood-2014-12-613927. Epub 2015 Jul 8.

Melphalan, prednisone, and thalidomide vs melphalan, prednisone, and lenalidomide (ECOG E1A06) in untreated multiple myeloma

A Keith Stewart  1 , Susanna Jacobus  2 , Rafael Fonseca  1 , Matthias Weiss  3 , Natalie S Callander  4 , Asher A Chanan-Khan  5 , S Vincent Rajkumar  6
Affiliations
Clinical Trial

Melphalan, prednisone, and thalidomide vs melphalan, prednisone, and lenalidomide (ECOG E1A06) in untreated multiple myeloma

A Keith Stewart et al. Blood. .

Abstract

This phase 3 trial (Eastern Cooperative Oncology Group [ECOG] E1A06) compared melphalan, prednisone, and thalidomide (MPT-T) with melphalan, prednisone, and lenalidomide (mPR-R) in patients with untreated multiple myeloma (MM). A noninferiority design was used, and inferiority was defined as a progression-free survival (PFS) hazard ratio (HR) of MPT-T/mPR-R ≤0.82. A total of 306 patients enrolled, with a median age of 75.7 years. Median follow-up was 40.7 months. Median time on therapy was 12.1 months and 23.1 months for the 46.6% of treated patients who received maintenance, with no differences by arm. Median PFS was 21 months on MPT-T and 18.7 months on mPR-R (HR, 0.84; 95% confidence interval, 0.64-1.09). Overall survival was 52.6 months (MPT-T) vs 47.7 months (mPR-R) (P = .476). Per-protocol response rates were 63.6% (MPT-T) and 59.9% (mPR-R) (P = .557). Grade ≥3 nonhematologic toxicity was 59.5% for MPT-T vs 40.0% for mPR-R (P = .001). Second malignancies were observed in 18 MPT-T patients vs 14 mPR-R patients. Quality-of-life analysis favored mPR-R by induction end (P = .007). Use of MPT-T or mPR-R in elderly patients with untreated MM demonstrates no statistical or clinically relevant differences in response rates, PFS, and OS; however, quality of life at end of induction was improved and lower toxicity reported with mPR-R. This trial was registered at www.clinicaltrials.gov as #NCT00602641.

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Figures

Figure 1
Figure 1
Study schema. PD, disease progression.
Figure 2
Figure 2
Investigator-adjudicated response rates.
Figure 3
Figure 3
ITT analysis. (A) PFS. (B) OS by arm of trial.
Figure 4
Figure 4
Forest plot. The prespecified subgroup analyses showed no significant differences. ISS, International Staging System; PS, performance status.
See this image and copyright information in PMC

References

    1. Kapoor P, Rajkumar SV, Dispenzieri A, et al. Melphalan and prednisone versus melphalan, prednisone and thalidomide for elderly and/or transplant ineligible patients with multiple myeloma: a meta-analysis. Leukemia. 2011;25(4):689–696. - PubMed
    1. San Miguel JF, Schlag R, Khuageva NK, et al. VISTA Trial Investigators. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med. 2008;359(9):906–917. - PubMed
    1. Benboubker L, Dimopoulos MA, Dispenzieri A, et al. FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014;371(10):906–917. - PubMed
    1. White DJ, Bahlis NJ, Marcellus DC, et al. Lenalidomide plus melphalan without prednisone for previously untreated older patients with multiple myeloma: a phase II trial. Clin Lymphoma Myeloma Leuk. 2013;13(1):19–24. - PubMed
    1. Palumbo A, Falco P, Corradini P, et al. GIMEMA--Italian Multiple Myeloma Network. Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: a report from the GIMEMA--Italian Multiple Myeloma Network. J Clin Oncol. 2007;25(28):4459–4465. - PubMed

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