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E1A06: A phase III trial comparing melphalan, prednisone, and thalidomide (MPT) versus melphalan, prednisone, and lenalidomide (MPR) in newly diagnosed multiple myeloma (MM).
J Clin Oncol 32:5s, 2014 (suppl; abstr 8511)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: Melphalan, prednisone and thalidomide (MPT) is an accepted regimen in newly diagnosed MM. Early studies suggested that lenalidomide (R) might be substituted for thalidomide (T) with equal efficacy and less toxicity. We present E1A06, a randomized, multicenter phase 3 trial comparing MPT vs. MPR in pts with untreated, symptomatic, transplant ineligible MM. Methods: The primary objective was PFS differences between pts receiving MPT: M 9 mg/m2 and P 100 mg p.o. each on days 1-4 with T 100 mg daily vs. MPR: M 5 mg/m2and P 100 mg p.o. each on days 1-4 with R 10 mg p.o. on days 1-21. MPT or MPR therapy was continued for twelve 28 day cycles followed by T 100mg or R 10mg daily until relapse. Aspirin prophylaxis was required. Pts were stratified by ISS stage (I-II vs. III) and age (<65 vs. ≥65). Inferiority of MPR was defined as a PFS treatment hazard ratio (HR) of MPT/MPR ≤ 0.82. Secondary objectives included OS between the arms, toxicities, response rates, depth of response and quality of life (QoL) change. Results: 306 pts were enrolled. Treatment arms were balanced for age, ISS stage and other major prognostic factors. Median age was 75.7y. The median follow-up was 40.7 months (m). Median time on therapy was 12m, and 23m for the 46% of pts on maintenance therapy, with no differences by arm. Per protocol partial response rate was 62% (MPT) vs. 61% (MPR) with no difference in VGPR/CR rates (18.8% vs. 23%). Grade ≥3 toxicity was 71.6% (MPT) vs. 56.7% (MPR); p=0.008. By ITT, the median PFS was 21m on MPT and 18.7m on MPR; HR 0.84 [95%CI: 0.64, 1.09]. The null hypothesis of inferiority of MPR was not rejected. Three year OS was identical by arm at 63% and median OS was not significantly different; p=0.476. Second primary malignancies were observed in 17 (MPT) vs. 14 (MPR) pts with incidence rates of 3.47 and 2.01 (/100 person years). DVT/PE occurred in 8.8% vs. 6.7% of pts. QoL analysis favored MPR by induction end; p=0.007. Conclusions: This phase III trial compares the efficacy of MPT and MPR in elderly patients with newly diagnosed MM. Response rates, PFS and OS were similar between the two arms; however, there was significantly better QOL at 12m and lower toxicity with MPR. Clinical trial information: NCT00602641.
Abstracts by A. Keith Stewart:
A study of real-time CLIA-enabled whole genome tumor sequencing: Results for testicular cancer and sarcomatoid RCC.Category: Genitourinary Cancer - Renal Cell Cancer
A randomized phase 3 trial of thalidomide and prednisone (TP) as maintenance therapy following autologous stem cell transplantation (ASCT) in patients with multiple myeloma (MM): An updated analysis of the NCIC Clinical Trials Group MY10 trial.
A tool to predict post-transcriptional instability related to the dysregulation of the SETD2 histone methyltransferase in renal cell carcinoma (RCC).
Presentations by A. Keith Stewart:
Phase I trial of obatoclax mesylate in combination with bortezomib for treatment of relapsed multiple myeloma.Session: Myeloma (Oral Abstract Session)
E1A06: An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone, and Thalidomide (MPT-T) versus Melphalan, Prednisone, and Lenalidomide (MPR-R) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High Dose TherapySession: Myeloma (Oral Abstract Session)