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Phase II study of dose-attenuated bortezomib, cyclophosphamide and dexamethasone ("VCD-Lite") in very old or otherwise toxicity-vulnerable adults with newly diagnosed multiple myeloma.

Publication ,  Journal Article
Tuchman, SA; Moore, JO; DeCastro, CD; Li, Z; Sellars, E; Kang, Y; Long, G; Gasparetto, CG
Published in: J Geriatr Oncol
May 2017

OBJECTIVES: Multiple myeloma (MM) primarily strikes older adults, but full-dose chemotherapy such as bortezomib (Velcade), cyclophosphamide and dexamethasone (VCD) is often excessively toxic to very old or frail adults and those with substantial comorbidities. We piloted dose-attenuated VCD ("VCD-Lite") in such vulnerable adults with newly diagnosed MM (NDMM). MATERIALS AND METHODS: Subjects with NDMM and a high risk of therapy-related toxicity due to factors above received bortezomib 1.3mg/m2 subcutaneously, cyclophosphamide 300mg/m2 and dexamethasone 40mg orally, all on days 1, 8, and 15 of a 28day cycle for eight cycles, followed by indefinite, alternating bortezomib and lenalidomide maintenance. Toxicity, overall response rate (ORR), progression-free and overall survival (PFS and OS) were determined. The Cancer and Aging Research Group geriatric assessment (CARG GA) was administered at baseline in an exploratory manner as a predictor of severe toxicity. RESULTS: 14 patients went on the study, which was closed early due to slow accrual. Intention-to-treat ORR was 64%. 64% of patients experienced grade ≥3 adverse events, the majority of which were unlikely therapy-related. Median PFS was 24.2months and OS 29.7months, with 14%, 36% and 29% of patients discontinuing study drugs due to toxicity, MM progression and other reasons respectively. Baseline CARG GA was successfully completed by all subjects but one. CONCLUSION: VCD-Lite is a viable option for vulnerable adults with NDMM. CARG GA is feasible. Further studies to optimize therapy and to explore CARG GA as a toxicity predictor are vital.

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Published In

J Geriatr Oncol

DOI

EISSN

1879-4076

Publication Date

May 2017

Volume

8

Issue

3

Start / End Page

165 / 169

Location

Netherlands

Related Subject Headings

  • Risk Factors
  • Multiple Myeloma
  • Male
  • Kaplan-Meier Estimate
  • Intention to Treat Analysis
  • Induction Chemotherapy
  • Humans
  • Geriatric Assessment
  • Female
  • Early Termination of Clinical Trials
 

Citation

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Tuchman, S. A., Moore, J. O., DeCastro, C. D., Li, Z., Sellars, E., Kang, Y., … Gasparetto, C. G. (2017). Phase II study of dose-attenuated bortezomib, cyclophosphamide and dexamethasone ("VCD-Lite") in very old or otherwise toxicity-vulnerable adults with newly diagnosed multiple myeloma. J Geriatr Oncol, 8(3), 165–169. https://doi.org/10.1016/j.jgo.2017.02.004
Tuchman, Sascha A., Joseph O. Moore, Carlos D. DeCastro, Zhiguo Li, Emily Sellars, Yubin Kang, Gwynn Long, and Cristina G. Gasparetto. “Phase II study of dose-attenuated bortezomib, cyclophosphamide and dexamethasone ("VCD-Lite") in very old or otherwise toxicity-vulnerable adults with newly diagnosed multiple myeloma.J Geriatr Oncol 8, no. 3 (May 2017): 165–69. https://doi.org/10.1016/j.jgo.2017.02.004.
Tuchman, Sascha A., et al. “Phase II study of dose-attenuated bortezomib, cyclophosphamide and dexamethasone ("VCD-Lite") in very old or otherwise toxicity-vulnerable adults with newly diagnosed multiple myeloma.J Geriatr Oncol, vol. 8, no. 3, May 2017, pp. 165–69. Pubmed, doi:10.1016/j.jgo.2017.02.004.
Tuchman SA, Moore JO, DeCastro CD, Li Z, Sellars E, Kang Y, Long G, Gasparetto CG. Phase II study of dose-attenuated bortezomib, cyclophosphamide and dexamethasone ("VCD-Lite") in very old or otherwise toxicity-vulnerable adults with newly diagnosed multiple myeloma. J Geriatr Oncol. 2017 May;8(3):165–169.
Journal cover image

Published In

J Geriatr Oncol

DOI

EISSN

1879-4076

Publication Date

May 2017

Volume

8

Issue

3

Start / End Page

165 / 169

Location

Netherlands

Related Subject Headings

  • Risk Factors
  • Multiple Myeloma
  • Male
  • Kaplan-Meier Estimate
  • Intention to Treat Analysis
  • Induction Chemotherapy
  • Humans
  • Geriatric Assessment
  • Female
  • Early Termination of Clinical Trials