BACKGROUND Data are lacking on whether lenalidomide maintenance therapy prolongs the time to disease progression after autologous hematopoietic stem-cell transplantation in patients with multiple myeloma. METHODS Between April 2005 and July 2009, we randomly assigned 460 patients who were younger than 71 years of age and had stable disease or a marginal, partial, or complete response 100 days after undergoing stem-cell transplantation to lenalidomide or placebo, which was administered until disease progression. The starting dose of lenalidomide was 10 mg per day (range, 5 to 15). RESULTS The study-drug assignments were unblinded in 2009, when a planned interim analysis showed a significantly longer time to disease progression in the lenalidomide group. At unblinding, 20% of patients who received lenalidomide and 44% of patients who received placebo had progressive disease or had died (P<0.001); of the remaining 128 patients who received placebo and who did not have progressive disease, 86 crossed over to lenalidomide. At a median follow-up of 34 months, 86 of 231 patients who received lenalidomide (37%) and 132 of 229 patients who received placebo (58%) had disease progression or had died. The median time to progression was 46 months in the lenalidomide group and 27 months in the placebo group (P<0.001). A total of 35 patients who received lenalidomide (15%) and 53 patients who received placebo (23%) died (P=0.03). More grade 3 or 4 hematologic adverse events and grade 3 non-hematologic adverse events occurred in patients who received lenalidomide (P<0.001 for both comparisons). Second primary cancers occurred in 18 patients who received lenalidomide (8%) and 6 patients who received placebo (3%). CONCLUSIONS Lenalidomide maintenance therapy, initiated at day 100 after hematopoietic stem-cell transplantation, was associated with more toxicity and second cancers but a significantly longer time to disease progression and significantly improved overall survival among patients with myeloma. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00114101.)

Dose density improves clinical outcomes significantly, despite the lower than expected number of events at this time. Sequential chemotherapy is as effective as concurrent chemotherapy.

Summary:uncertainty of a cure with high-dose, intensive treatment regimens. While there has been increasing attention paid to QOL issues in BMT patients, [3][4][5][6][7][8][9] there have been few We developed a 12-item bone marrow transplant subscale (BMTS) for the general Functional Assessment of instruments designed specifically to measure quality of life in the transplant patient population. One other available Cancer Therapy (FACT) measure. The subscale combined with the FACT, (FACT-BMT) is a 47-item, valid instrument 10 was developed for post-treatment survivors of bone marrow transplantation, so its appropriateness for and reliable measure of five dimensions of quality of life in bone marrow transplant patients. The three-step patients during transplantation is unknown.Health-related quality of life measurement has evolved validation process involved the generation and selection of BMT-specific items and the testing of the overall meaover the past 25 years to the point where the Food and Drug Administration recommends QOL assessment for any sure. Items were selected from a list produced by seven oncology experts and 15 patients and were designed to new drug therapies developed in cancer medicine. 11,12Initially, general measures of psychological health and assess content not represented in the general FACT items. A total of 182 patients completed the FACT-BMT functional status were used to assess patient response to cancer therapies and other areas such as cardiac care and at baseline, prior to BMT. An analysis measuring sensitivity to change was performed with 74 patients after renal transplantation. Cancer specific instruments were developed to measure the particular issues faced by cancer transplantation and 60 patients over the three timepoints of baseline, hospital discharge and 100 days. The patients. 13,14 Further advancement of QOL measurement technology has produced site-specific scales that FACT-BMT and all subscales were correlated, sensitivity to change was measured, and the internal consistaccompany general cancer measures and are utilized to assess the unique problems faced by patients with differency for each scale was calculated. Coefficients of reliability and validity ranged from 0.86 to 0.89 for the ent diagnoses.14,15While many uses of QOL data have been described, 16 entire FACT-BMT and 0.54 to 0.63 for the BMTS. The BMTS was able to discriminate patients on the basis of there are three primary reasons why QOL measurement is important, especially in a BMT population. 17 First, when performance status rating and also demonstrated sensitivity to change over time. The FACT-BMT has good two treatments are compared in a clinical trial, QOL data may provide additional information upon which to base psychometric properties for use in assessing quality of life in bone marrow transplant patients. The addition treatment decisions. Since BMT regimens are relatively new compared to standard chemotherapeutic and radioof the bone marrow transplant subscale to the general FACT measure makes it an e...

A postinduction course of high-dose cytarabine can provide equivalent disease-free survival and somewhat better overall survival than autologous marrow transplantation in adults with acute myeloid leukemia.

The HDT and SDT regimens used in S9321 yielded comparable response rates and PFS and OS durations. IFN maintenance therapy did not benefit patients who achieved > or = 75% tumor reduction on either arm.

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Marrow is cryopreserved for use in autologous bone marrow transplants, but little is known of the incidence of reactions in patients transfused with these cryopreserved marrows. Reactions in patients transfused during a 4-year period with 134 autologous marrows cryopreserved in dimethyl sulfoxide (DMSO) were compared with those in patients transfused with marrow that had been collected from HLA-compatible donors and that had not been cryopreserved. Patients transfused with cryopreserved marrow had significantly more nausea (44.8 vs. 14.1%; p less than 0.0005), vomiting (23.9 vs. 8.5%; p less than 0.01), chills (31.3 vs. 1.4%; p less than 0.0005), and fever (17.9 vs. 0%; p less than 0.005) than patients transfused with fresh allogeneic marrow. The incidence of emesis correlated with the dose of DMSO received, but that of nausea did not. All cryopreserved marrows were cultured for bacteria at the time of transfusion and 17 (12.7%) were found to be positive. Only 1 of the 17 patients transfused with culture-positive marrow developed sepsis during the transplant course with the same organism that was present in the transfused marrow. Although the reactions in donors transfused with cryopreserved marrow were readily treated, this study suggests that the incidence of some reactions might be decreased by reducing the dose of DMSO transfused. Bacterial contamination of transfused marrow was a worrisome complication, and efforts should be made to improve marrow collection and processing techniques to minimize that risk.