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 journalArticle

2 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)1-6
Number of pages6
JournalLeukemia and Lymphoma
DOIs
StateAccepted/In press - Oct 25 2017
Externally publishedYes

Fingerprint

Melphalan
Stem Cell Transplantation
Multiple Myeloma
Bone Marrow
Transplants
Maximum Tolerated Dose
Autografts
Disease-Free Survival
Neutrophils
Stem Cells
Blood Platelets
Survival
Therapeutics

Keywords

  • autologous stem cell transplant
  • conditioning regimens
  • Multiple myeloma
  • total marrow irradiation

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

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

In: Leukemia and Lymphoma, 25.10.2017, p. 1-6.

Research output: Contribution to journalArticle

Patel, Pritesh ; Oh, Annie L. ; Koshy, Matthew ; Sweiss, Karen ; Saraf, Santosh L. ; Quigley, John G. ; Khan, Irum ; Mahmud, Nadim ; Hacker, Eileen ; Ozer, Howard ; Peace, David J. ; Weichselbaum, Ralph R. ; Aydogan, Bulent ; Rondelli, Damiano. / 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. In: Leukemia and Lymphoma. 2017 ; pp. 1-6.
@article{823d071544a74e179031e1f4905c2612,
title = "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",
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.",
keywords = "autologous stem cell transplant, conditioning regimens, Multiple myeloma, total marrow irradiation",
author = "Pritesh Patel and Oh, {Annie L.} and Matthew Koshy and Karen Sweiss and Saraf, {Santosh L.} and Quigley, {John G.} and Irum Khan and Nadim Mahmud and Eileen Hacker and Howard Ozer and Peace, {David J.} and Weichselbaum, {Ralph R.} and Bulent Aydogan and Damiano Rondelli",
year = "2017",
month = "10",
day = "25",
doi = "10.1080/10428194.2017.1390231",
language = "English (US)",
pages = "1--6",
journal = "Leukemia and Lymphoma",
issn = "1042-8194",
publisher = "Informa Healthcare",

}

TY - JOUR

T1 - 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

AU - Patel, Pritesh

AU - Oh, Annie L.

AU - Koshy, Matthew

AU - Sweiss, Karen

AU - Saraf, Santosh L.

AU - Quigley, John G.

AU - Khan, Irum

AU - Mahmud, Nadim

AU - Hacker, Eileen

AU - Ozer, Howard

AU - Peace, David J.

AU - Weichselbaum, Ralph R.

AU - Aydogan, Bulent

AU - Rondelli, Damiano

PY - 2017/10/25

Y1 - 2017/10/25

N2 - 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.

AB - 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.

KW - autologous stem cell transplant

KW - conditioning regimens

KW - Multiple myeloma

KW - total marrow irradiation

UR - http://www.scopus.com/inward/record.url?scp=85032196805&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85032196805&partnerID=8YFLogxK

U2 - 10.1080/10428194.2017.1390231

DO - 10.1080/10428194.2017.1390231

M3 - Article

SP - 1

EP - 6

JO - Leukemia and Lymphoma

JF - Leukemia and Lymphoma

SN - 1042-8194

ER -