Randomized, Open-Label, Non-Inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients (Pts) with Relapsed or Refractory Multiple Myeloma (RRMM): Body Weight Subgroup Analysis of Columba

被引：2

作者：

Mateos, Maria-Victoria ^{[1
]}

Usmani, Saad Z. ^{[2
]}

Grosicki, Sebastian ^{[3
]}

Vorobyev, Vladimir I. ^{[4
]}

Spicka, Ivan ^{[5
]}

Hungria, Vania T. M. ^{[6
]}

Korenkova, Sibirina ^{[7
]}

Bahlis, Nizar ^{[8
]}

Flogegard, Max ^{[9
]}

Blade, Joan ^{[10
]}

Moreau, Philippe ^{[14
]}

Kaiser, Martin F. ^{[11
]}

Iida, Shinsuke ^{[12
]}

Laubach, Jacob P. ^{[13
]}

Masterson, Tara ^{[15
]}

Lantz, Kristen Anne ^{[15
]}

O'Rourke, Lisa ^{[15
]}

Qin, Xiang ^{[16
]}

Parasrampuria, Dolly A. ^{[15
]}

Heuck, Christoph ^{[15
]}

Qi, Ming ^{[15
]}

Nahi, Hareth ^{[17
]}

机构：

[1] Univ Hosp Salamanca, IBSAL, Salamanca, Spain

[2] Atrium Hlth, Levine Canc Inst, Charlotte, NC USA

[3] Med Univ Silesian, Sch Publ Hlth, Dept Hematol & Canc Prevent, Katowice, Poland

[4] SP Botkin City Clin Hosp, Moscow, Russia

[5] Gen Fac Hosp, Prague, Czech Republic

[6] Santa Casa Med Sch, Sao Paulo, Brazil

[7] Kiev Ctr Bone Marrow Transplantat, Kiev, Ukraine

[8] Univ Calgary, Arnie Charbonneau Canc Inst, Calgary, AB, Canada

[9] Falun Gen Hosp, Dept Internal Med, Falun, Sweden

[10] Hosp Clin Barcelona, IDIBAPS, Barcelona, Spain

[11] Inst Canc Res, Div Mol Pathol, Sutton, Surrey, England

[12] Nagoya City Univ, Grad Sch Med Sci, Dept Hematol & Oncol, Nagoya, Aichi, Japan

[13] Harvard Med Sch, Dana Farber Canc Inst, Dept Hematol & Oncol, Boston, MA 02115 USA

[14] Univ Hosp Nantes, Nantes, France

[15] Janssen Res & Dev LLC, Spring House, PA USA

[16] Janssen Res & Dev LLC, Raritan, NJ USA

[17] Karolinska Inst, Karolinska Univ Hosp, Div Hematol, Dept Med, Huddinge, Sweden

来源：

BLOOD | 2019年 / 134卷

关键词：

D O I：

10.1182/blood-2019-122501

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

1906

引用

页数：5

共 50 条

[1] Randomized, open-label, non-inferiority, phase 3 study of subcutaneous (SC) versus intravenous (IV) daratumumab (DARA) administration in patients with relapsed or refractory multiple myeloma (RRMM): COLUMBA.
Usmani, Saad Zafar
Mateos, Maria-Victoria
Bahlis, Nizar J.
Grosicki, Sebastian
Spencer, Andrew
Bandekar, Rajesh
Masterson, Tara J.
Clemens, Pamela L.
Heuck, Christoph Johann
Qi, Ming
Nahi, Hareth
JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (15)
[2] Efficacy and safety of the randomized, open-label, non-inferiority, phase 3 study of subcutaneous (SC) versus intravenous (IV) daratumumab (DARA) administration in patients (pts) with relapsed or refractory multiple myeloma (RRMM): COLUMBA.
Mateos, Maria-Victoria
Nahi, Hareth
Legiec, Wojciech
Grosicki, Sebastian
Vorobyev, Vladimir
Spicka, Ivan
Hungria, Vania T. M.
Korenkova, Sibirina
Bahlis, Nizar J.
Flogegard, Max
Blade, Joan
Moreau, Philippe
Kaiser, Martin
Iida, Shinsuke
Laubach, Jacob
Ahmadi, Tahamtan
Parasrampuria, Dolly A.
Peng, Lixian
Qi, Ming
Usmani, Saad Zafar
JOURNAL OF CLINICAL ONCOLOGY, 2019, 37 (15)
[3] Randomized, Open-Label, Non-Inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients with Relapsed or Refractory Multiple Myeloma: Columba Update
Usmani, Saad Z.
Mateos, Maria-Victoria
Nahi, Hareth
Grosicki, Sebastian
Vorobyev, Vladimir I.
Spicka, Ivan
Hungria, Vania T. M.
Korenkova, Sibirina
Flogegard, Max
Blade, Joan
Moreau, Philippe
Kaiser, Martin F.
Iida, Shinsuke
Laubach, Jacob P.
Masterson, Tara
Lantz, Kristen Anne
O'Rourke, Lisa
Heuck, Christoph
Qin, Xiang
Parasrampuria, Dolly A.
Qi, Ming
Bahlis, Nizar
BLOOD, 2019, 134
[4] Phase 3, open-label, non-inferiority study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma: body weight subgroup analysis of Columba
Kaiser, M.
Mateos, M. -V.
Usmani, S. Z.
Grosicki, S.
Vorobyev, V.
Spicka, I.
Hungria, V.
Korenkova, S.
Bahlis, N.
Flogegard, M.
Blade, J.
Moreau, P.
Iida, S.
Laubach, J.
Masterson, T.
Lantz, K.
O'Rourke, L.
Qin, X.
Parasrampuria, D. A.
Heuck, C.
Qi, M.
Nahi, H.
BRITISH JOURNAL OF HAEMATOLOGY, 2020, 189 : 22 - 22
[5] Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial
Mateos, Maria-Victoria
Nahi, Hareth
Legiec, Wojciech
Grosicki, Sebastian
Vorobyev, Vladimir
Spicka, Ivan
Hungria, Vania
Korenkova, Sibirina
Bahlis, Nizar
Flogegard, Max
Blade, Joan
Moreau, Philippe
Kaiser, Martin
Iida, Shinsuke
Laubach, Jacob
Magen, Hila
Cavo, Michele
Hulin, Cyrille
White, Darrell
De Stefano, Valerio
Clemens, Pamela L.
Masterson, Tara
Lantz, Kristen
O'Rourke, Lisa
Heuck, Christoph
Qin, Xiang
Parasrampuria, Dolly A.
Yuan, Zhilong
Xu, Steven
Qi, Ming
Usmani, Saad Z.
LANCET HAEMATOLOGY, 2020, 7 (05): : E370 - E380
[6] Greater Treatment Satisfaction in Patients Receiving Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) for Relapsed or Refractory Multiple Myeloma (RRMM): COLUMBA
Usmani, Saad
Mateos, Maria-Victoria
Hungria, Vania
Iida, Shinsuke
Bahlis, Nizar J.
Nahi, Hareth
Magen, Hila
Cavo, Michele
Hulin, Cyrille
White, Darrell
De Stefano, Valerio
Slavcev, Mary
Heuck, Christoph
Qin, Xiang
Masterson, Tara
Lantz, Kristen
Gries, Katharine
CLINICAL LYMPHOMA MYELOMA & LEUKEMIA, 2019, 19 (10): : E247 - E248
[7] Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma
Usmani, Saad Z.
Nahi, Hareth
Legiec, Wojciech
Grosicki, Sebastian
Vorobyev, Vladimir
Spicka, Ivan
Hungria, Vania
Korenkova, Sibirina
Bahlis, Nizar J.
Flogegard, Max
Blade, Joan
Moreau, Philippe
Kaiser, Martin
Iida, Shinsuke
Laubach, Jacob
Magen, Hila
Cavo, Michele
Hulin, Cyrille
White, Darrell
De Stefano, Valerio
Lantz, Kristen
O'Rourke, Lisa
Heuck, Christoph
Delioukina, Maria
Qin, Xiang
Nnane, Ivo
Qi, Ming
Mateos, Maria-Victoria
HAEMATOLOGICA, 2022, 107 (10) : 2408 - 2417
[8] Corticosteriod tapering in patients (Pts) with relapsed or refractory multiple myeloma (RRMM) receiving subcutaneous daratumumab (DARA SC): Part 3 of the open-label, multicenter, phase Ib PAVO Study.
Nahi, Hareth
Usmani, Saad Zafar
Mateos, Maria-Victoria
van de Donk, Niels W. C. J.
Moreau, Philippe
Oriol, Albert
Plesner, Torben
Yang, Shiyi
Hellemans, Peter
Tromp, Brenda J.
Luo, Man
Zemlickis, Donna
Farnsworth, Andrew
Chari, Ajai
JOURNAL OF CLINICAL ONCOLOGY, 2020, 38 (15)
[9] Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study
Moreau, Philippe
Pylypenko, Halyna
Grosicki, Sebastian
Karamanesht, Ievgenii
Leleu, Xavier
Grishunina, Maria
Rekhtman, Grigoriy
Masliak, Zvenyslava
Robak, Tadeusz
Shubina, Anna
Arnulf, Bertrand
Kropff, Martin
Cavet, James
Esseltine, Dixie-Lee
Feng, Huaibao
Girgis, Suzette
van de Velde, Helgi
Deraedt, William
Harousseau, Jean-Luc
LANCET ONCOLOGY, 2011, 12 (05): : 431 - 440
[10] Subcutaneous daratumumab (DARA) in patients (Pts) with relapsed or refractory multiple myeloma (RRMM): Part 2 update of the open-label, multicenter, dose escalation phase 1b study (PAVO).
Chari, Ajai
Usmani, Saad Zafar
Mateos, Maria-Victoria
Van De Donk, Niels
Kaufman, Jonathan L.
Moreau, Philippe
Rocafiguera, Albert Oriol
Plesner, Torben
Benboubker, Lotfi
Liu, Kevin
Hellemans, Peter
Masterson, Tara J.
Clemens, Pamela L.
Farnsworth, Andrew
Nahi, Hareth
San-Miguel, Jesus
JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (15)

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