A phase 1 trial of autologous stem cell transplantation conditioned with melphalan 200 mg/m2 and total marrow irradiation (TMI) in patients with relapsed/refractory multiple myeloma

Pritesh Patel; Annie L. Oh; Matthew Koshy; Karen Sweiss; Santosh L. Saraf; John G. Quigley; Irum Khan; Nadim Mahmud; Eileen Hacker; Howard Ozer; David J. Peace; Ralph R. Weichselbaum; Bulent Aydogan; Damiano Rondelli

doi:10.1080/10428194.2017.1390231

A phase 1 trial of autologous stem cell transplantation conditioned with melphalan 200 mg/m² and total marrow irradiation (TMI) in patients with relapsed/refractory multiple myeloma

Pritesh Patel, Annie L. Oh, Matthew Koshy, Karen Sweiss, Santosh L. Saraf, John G. Quigley, Irum Khan, Nadim Mahmud, Eileen Hacker, Howard Ozer, David J. Peace, Ralph R. Weichselbaum, Bulent Aydogan, Damiano Rondelli

Research output: Contribution to journal › Article › peer-review

19 Scopus citations

Abstract

In this phase 1 study, we tested increasing doses of total marrow irradiation (TMI) in addition to standard intravenous melphalan at 200 mg/m² (Mel200) in the conditioning regimen prior to autologous stem cell transplant (ASCT) for multiple myeloma (NCT02043847). Twelve patients aged 18–75 with relapsed myeloma were enrolled in the study and received Mel200 and TMI 3 Gy (n = 3), 6 Gy (n = 3), or 9 Gy (n = 6) prior to transplant. There were no grade 4 extra-hematologic toxicities and a maximum tolerated dose was not reached. Median time to neutrophil and platelet engraftment was 11 and 13 d, respectively. At day 90, 73% of patients were in CR or VGPR. Median progression free survival (PFS) was 449 d and median overall survival (OS) was 966 d. We conclude that TMI at a dose of 9 Gy can be safely combined with Mel200 in therapeutic regimens for autologous transplant. Initial clinical results will prompt a phase 2 study.

Original language	English (US)
Pages (from-to)	1666-1671
Number of pages	6
Journal	Leukemia and Lymphoma
Volume	59
Issue number	7
DOIs	https://doi.org/10.1080/10428194.2017.1390231
State	Published - Jul 3 2018
Externally published	Yes

Keywords

autologous stem cell transplant
conditioning regimens
Multiple myeloma
total marrow irradiation

ASJC Scopus subject areas

Hematology
Oncology
Cancer Research

Access to Document

10.1080/10428194.2017.1390231

Cite this

Patel, P., Oh, A. L., Koshy, M., Sweiss, K., Saraf, S. L., Quigley, J. G., Khan, I., Mahmud, N., Hacker, E., Ozer, H., Peace, D. J., Weichselbaum, R. R., Aydogan, B., & Rondelli, D. (2018). A phase 1 trial of autologous stem cell transplantation conditioned with melphalan 200 mg/m² and total marrow irradiation (TMI) in patients with relapsed/refractory multiple myeloma. Leukemia and Lymphoma, 59(7), 1666-1671. https://doi.org/10.1080/10428194.2017.1390231

A phase 1 trial of autologous stem cell transplantation conditioned with melphalan 200 mg/m² and total marrow irradiation (TMI) in patients with relapsed/refractory multiple myeloma. / Patel, Pritesh; Oh, Annie L.; Koshy, Matthew et al.
In: Leukemia and Lymphoma, Vol. 59, No. 7, 03.07.2018, p. 1666-1671.

Research output: Contribution to journal › Article › peer-review

Patel, P, Oh, AL, Koshy, M, Sweiss, K, Saraf, SL, Quigley, JG, Khan, I, Mahmud, N, Hacker, E, Ozer, H, Peace, DJ, Weichselbaum, RR, Aydogan, B & Rondelli, D 2018, 'A phase 1 trial of autologous stem cell transplantation conditioned with melphalan 200 mg/m² and total marrow irradiation (TMI) in patients with relapsed/refractory multiple myeloma', Leukemia and Lymphoma, vol. 59, no. 7, pp. 1666-1671. https://doi.org/10.1080/10428194.2017.1390231

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abstract = "In this phase 1 study, we tested increasing doses of total marrow irradiation (TMI) in addition to standard intravenous melphalan at 200 mg/m2 (Mel200) in the conditioning regimen prior to autologous stem cell transplant (ASCT) for multiple myeloma (NCT02043847). Twelve patients aged 18–75 with relapsed myeloma were enrolled in the study and received Mel200 and TMI 3 Gy (n = 3), 6 Gy (n = 3), or 9 Gy (n = 6) prior to transplant. There were no grade 4 extra-hematologic toxicities and a maximum tolerated dose was not reached. Median time to neutrophil and platelet engraftment was 11 and 13 d, respectively. At day 90, 73% of patients were in CR or VGPR. Median progression free survival (PFS) was 449 d and median overall survival (OS) was 966 d. We conclude that TMI at a dose of 9 Gy can be safely combined with Mel200 in therapeutic regimens for autologous transplant. Initial clinical results will prompt a phase 2 study.",

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