Pomalidomide and Dexamethasone in Relapsed Myeloma: Results of 225 Patients Treated in Five Cohorts Over Three Years

• Published in: Blood 2011-11, Vol.118 (21), p.3963-3963
• Main Authors: Lacy, Martha Q, LaPlant, Betsy R., Laumann, Kristina, Gertz, Morie A, Hayman, Suzanne R, Buadi, Francis K, Dispenzieri, Angela, Kumar, Shaji, Lust, John A., Russell, Stephen, Dingli, David, Zeldenrust, Steven R, Greipp, Philip R., Fonseca, Rafael, Bergsagel, P.Leif, Roy, Vivek, Stewart, Keith, Reeder, Craig B., Hall, Robert L, Rajkumar, S. Vincent, Mikhael, Joseph R.
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V118.21.3963.3963

Abstract 3963 Pomalidomide at doses of 2 or 4 mg/d has demonstrated excellent activity in patients with relapsed multiple myeloma (MM). Between November 2007 and November 2010, we opened 5 sequential phase 2 trials using the pomalidomide at differing doses with weekly dexamethasone (Pom/dex) regimen to study the efficacy of this regimen. The five cohorts consisted of: Cohort 1 (N=60): relapsed MM with 1–3 prior regimens, 2 mg dose; Cohort 2 (N=34): lenalidomide refractory, 2 mg dose; Cohort 3 (N=35): bortezomib/lenalidomide refractory, 2 mg dose; Cohort 4 (N=35): bortezomib/lenalidomide refractory, 4 mg dose; and Cohort 5 (N=60) lenalidomide refractory, 1–3 prior regimens, 4 mg dose. Pomalidomide was given orally 2 mg daily or 4mg daily on days 1–28 of a 28-day cycle with oral dexamethasone given 40 mg daily on days 1, 8, 15 and 22. Response was assessed by the International Myeloma Working Group Uniform Response criteria. All patients received aspirin 325 mg daily for DVT prophylaxis or full dose anticoagulation. A total of 225 patients were enrolled across all 5 cohorts. One patient was ineligible and excluded from analysis. The median age was 63 years (32.0–88.0). The median time since diagnosis was 53 months. Forty percent had high-risk molecular markers. Eighty-nine percent had received previous IMIDs including thalidomide (53%) and lenalidomide (81%). Sixty-two percent had previous bortezomib and 73% had prior transplant. The median follow-up is 12.6 months, but varies from 9.4 months for the most recent cohort to 30 months for the first cohort. Sixty-nine percent are alive and 30% remain progression free. Toxicities ≥ grade 3 are shown in table 1 and patient outcomes are shown in Table 2. Table 1Toxicity, grade 3 or higher2mg2mg2mg4mg4mg1–3 RegLen RefractoryBortz/Len RefractoryBortz/Len RefractoryLen Refractory 1–3 RegN=60N=34N=35N=35N=60HematologicNeutropenia48%41%51%66%48%Anemia10%18%26%26%13%Platelets12%12%31%31%8%Non HematologicFatigue25%18%9%9%8%Pneumonia18%20%29%3%15%Neuropathy2%003%2%Len: lenalidomide; Bortz:bortezomib;Table 2Patient Outcomes2mg2mg2mg4mg4mg1–3 RegLen RefractoryBortz/Len RefractoryBortz/Len RefractoryLen Refractory 1–3 RegN=60N=34N=35N=35N=60All cycle Confirmed Response Rate (≥PR)65%32%26%29%37%Median time to response1.7 mo2.0 mo1 mo1.8 mo1.1 moDuration of response121 mo9 mo16 mo3 moNAOverall Survival140 mo27 mo17 mo9 moNA6 Months OS95%85%76%67%93%Progression Free Survival113 mo4.7 mo6.5 mo3.3 mo7.9 mo6 Months PFS73%44%56%37%6