Study Description

The study population will consist of adults diagnosed with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD. The study consists of 3 phases: a screening phase (up to 28 days), a treatment phase, and a follow-up phase. Efficacy, pharmacokinetics, immunogenicity, biomarkers and safety will be assessed at scheduled time. Follow-up will continue until the end of the data collection period, approximately 24 months after the last participant was randomized or when the median overall survival for both arms has been reached, whichever occurs first. The primary hypotheses is that the ORR and maximum Ctrough for Dara SC 1800 milligram (mg) are not inferior to the ORR and maximum Ctrough, respectively, for Dara IV 16 mg per kilogram (mg/kg) in participants with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD.

Condition or Disease	Intervention/Treatment
Multiple Myeloma	Drug: Dara SC Drug: Dara IV

Study Design

Study Type	Interventional
Actual Enrollment	522 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
Official Title	A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma
Study Start Date	October 27, 2017
Actual Primary Completion Date	June 27, 2019
Actual Study Completion Date	January 12, 2024

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Dara SC Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks.	Drug: Dara SC Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
Dara IV Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.	Drug: Dara SC Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. Drug: Dara IV

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate (ORR) [Up to 1 year 8 months]
   ORR was defined as the percentage of participants who achieved partial response (PR) or better according to International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligrams (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, >=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas was also required.
2. Maximum Trough Concentration (Ctrough) of Daratumumab [Predose on Cycle 3 Day 1 (each cycle of 28 days)]
   Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.

Secondary Outcome Measures

1. Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR) [Up to 3 years]
   Percentage of participants with treatment-emergent infusion-related reactions were reported.
2. Progression Free Survival (PFS) [Up to 3 years]
   PFS was defined as time from date of randomization to either progression of disease (PD), death due to any cause, whichever occurs first. IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M component (absolute increase must be >=0.5 gram per deciliter (g/dL), Urine M-component (absolute increase must be >=200 mg/24 hours), Participants without measurable serum and urine Mprotein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be >10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
3. Percentage of Participants With Very Good Partial Response (VGPR) or Better [Up to 3 years]
   VGPR or better was defined as the percentage of participants who achieved VGPR or better (VGPR, complete response (CR) or stringent complete response [sCR]), based on computerized algorithm as per IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligrams (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PCs) in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescencea or 2- to 4 color flow cytometry.
4. Percentage of Participants With Complete Response (Including sCR) or Better [Up to 3 years]
   CR or better was defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. IMWG criteria for CR- negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by IHC, immunofluorescencea or 2- to 4 color flow cytometry.
5. Time to Next Therapy [Up to 3 years]
   Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy.
6. Overall Survival (OS) [Up to 3 years]
   OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
7. Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ) [Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)]
   Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.
8. Duration of Response [Up to 3 years]
   Duration of response was defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria. PD was defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
9. Time to Partial Response (PR) or Better [Up to 3 years]
   Time to PR or better was defined as the time from randomization until onset of first response of PR or better.
10. Time to Very Good Partial Response (VGPR) or Better [Up to 3 years]
    Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better.
11. Time to Complete Response (CR) or Better [Up to 3 years]
    Time to CR or better was defined as the time from randomization until onset of first CR or better.

Eligibility Criteria

Ages Eligible for Study	18 Years and Older (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	Evidence of a response (Partial response [PR] or better based on investigator's determination of response by international myeloma working group [IMWG] criteria) to at least 1 prior treatment regimen Received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be considered prior lines of therapy Documented multiple myeloma as defined by the criteria below: Multiple myeloma diagnosis according to the IMWG diagnostic criteria Measurable disease at Screening as defined by any of the following: Serum M-protein level >=1.0 gram per deciliter (g/dL) or urine M-protein level >=200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 Meet the clinical laboratory criteria as specified in the protocol Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization
Exclusion Criteria	Received daratumumab or other anti-CD38 therapies previously Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) before treatment Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing) Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant) History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years

Contacts and Locations

Sponsors and Collaborators	Janssen Research & Development, LLC
Locations	Dana-Farber Cancer Institute | Boston, Massachusetts, United States, 02215-5418 Levine Cancer Institute | Charlotte, North Carolina, United States, 28204 Royal Prince Alfred Hospital | Camperdown, Australia, 2050 St. Vincent's Hospital Melbourne | Fitzroy, Australia, 3065 Alfred Health | Melbourne, Australia, 3004 Fiona Stanley Hospital | Murdoch, Australia, 6150 Sir Charles Gairdner Hospital | Nedlands, Australia, 6009 Calvary Mater Newcastle Hospital | Waratah, Australia, 2298 The Queen Elizabeth Hospital | Woodville South, Australia, 5011 Princess Alexandra Hospital | Woolloongabba, Australia, 4102 Fundacao Pio XII | Barretos, Brazil, 14784-400 Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN | Florianopolis, Brazil, 88034-000 Fundacao Doutor Amaral Carvalho | Jau, Brazil, 17210-080 Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia | Joinville, Brazil, 89201-260 Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo | Passo Fundo, Brazil, 99010-090 Hospital das Clinicas de Porto Alegre | Porto Alegre, Brazil, 90035-903 Instituto de Educacao, Pesquisa e Gestao em Saude | Rio de Janeiro, Brazil, 22775-001 CEHON | Salvador, Brazil, 45995-000 Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base | Sao Jose do Rio Preto, Brazil, 15090-000 Clinica Sao Germano | São Paulo, Brazil, 01455-010 Hospital Das Clinicas Da Faculdade De Medicina Da USP | São Paulo, Brazil, 05403-010 Tom Baker Cancer Centre | Calgary, Alberta, Canada, T2N 4N2 Cross Cancer Institute | Edmonton, Alberta, Canada, T6G 1Z2 The Gordon & Leslie Diamond Health Care Center | Vancouver, British Columbia, Canada, V5Z 1M9 QEII Health Sciences Centre | Halifax, Nova Scotia, Canada, B3H 1V7 Victoria Hospital | London, Ontario, Canada, N6A 5W9 Princess Margaret Hospital | Toronto, Ontario, Canada, M5G 1X6 CHU de Québec -L'Hôtel-Dieu de Québec | Québec, Quebec, Canada, G1R 2J6 Fakultni nemocnice Brno | Brno, Czechia, 625 00 Fakultni nemocnice Hradec Kralove | Hradec Kralove, Czechia, 500 05 Fakultní nemocnice Olomouc | Olomouc, Czechia, 779 00 Fakultni nemocnice Ostrava | Ostrava, Czechia, 70852 Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni | Plzen, Czechia, 323 00 Fakultni nemocnice Kralovske Vinohrady | Praha 10, Czechia, 100 34 Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie | Praha 2, Czechia, 128 08 CHU Caen - Côte de Nacre | Caen, France, 14033 Hopital Claude Huriez | Lille Cedex, France, 59000 CHU de Nantes hotel Dieu | Nantes Cedex 1, France, 44093 CHU de Boreaux | Pessac, France, 33604 Centre hospitalier Lyon-Sud | Pierre-Bénite, France, 69495 CHU Poitiers - Hôpital la Milétrie | Poitiers, France, 86021 CHU Nancy Brabois | Vandoeuvre Les Nancy, France, 54511 Alexandra General Hospital of Athens | Athens Attica, Greece, 115 28 Hillel Yaffe Medical Center - Oncology | Hadera, Israel, 38100 Rambam Med.Center - Hematology Institute | Haifa, Israel, 31096 Carmel Medical Center | Haifa, Israel, 3436212 Hadassah Medical Center | Jerusalem, Israel, 91120 Rabin Medical Center Beilinson Campus | Petah Tikva, Israel, 49100 Sheba Medical Center Tel Hashomer | Ramat Gan, Israel, 52621 Tel Aviv Sourasky Medical Center | Tel Aviv, Israel, 64239 Policlinico Sant'Orsola Malpighi | Bologna, Italy, 40138 Fondazione IRCCS Istituto Nazionale dei Tumori | Milano, Italy, 20133 Ospedale Villa Sofia-Cervello | Palermo, Italy, 90146 Fondazione IRCCS Policlinico San Matteo | Pavia, Italy, 27100 Azienda USL di Piacenza | Piacenza, Italy, 29121 Università di Roma La Sapienza | Roma, Italy, 00161 Policlinico Universitario Agostino Gemelli | Roma, Italy, 00168 A.O.U. Città della Salute e della Scienza | Torino, Italy, 10126 Fukuoka University Hospital | Fukuoka, Japan, 814-0180 Chugoku Central Hospital | Fukuyama, Japan, 720-0001 Ogaki Municipal Hospital | Gifu, Japan, 503-8502 Gunma University Hospital | Gunma, Japan, 371-0034 Kobe City Medical Center General Hospital | Hyogo, Japan, 650-0047 Iwate Medical University Hospital | Iwate, Japan, 020-8505 University Hospital Kyoto Perfectural University of Medicine | Kyoto, Japan, 602-8566 Matsuyama Red Cross Hospital | Matsuyama, Japan, 790-8524 Japanese Red Cross Nagoya Daini Hospital | Nagoya, Japan, 466-8650 Nagoya City University Hospital | Nagoya, Japan, 467-8602 Niigata Cancer Center Hospital | Niigata, Japan, 951-8566 National Hospital Organization Okayama Medical Center | Okayama, Japan, 701-1192 Osaka University Hospital | Osaka, Japan, 565-0871 National Hospital Organization Sendai Medical Center | Sendai-City, Japan, 983-8520 National Hospital Organization Shibukawa Medical Center | Shibukawa, Japan, 377-0280 Japanese Red Cross Medical Center | Shibuya, Japan, 150-8935 Pusan National University Hospital | Busan, Korea, Republic of, 49241 National Cancer Center | Goyang-Si, Korea, Republic of, 10408 Gachon University Gil Medical Center | Incheon, Korea, Republic of, 21565 Severance Hospital | Seoul, Korea, Republic of, 03722 Asan Medical Center | Seoul, Korea, Republic of, 05505 Samsung Medical Center | Seoul, Korea, Republic of, 06351 The Catholic University of Korea Seoul St. Mary's Hospital | Seoul, Korea, Republic of, 06591 Ulsan University Hospital | Ulsan, Korea, Republic of, 44033 Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza | Brzozow, Poland, 36-200 Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy | Bydgoszcz, Poland, 85-168 Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich | Chorzów, Poland, 41-500 Szpitale Pomorskie Sp z o o | Gdynia, Poland, 81-519 Szpital Uniwersytecki w Krakowie | Krakow, Poland, 31-501 Wojewodzki Szpital Specjalistyczny w Legnicy | Legnica, Poland, 59-220 Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie | Lublin, Poland, 20-081 Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego | Poznan, Poland, 60-569 Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warszawa, Poland, 02-781 Emergency Hospital of Dzerzhinsk | Dzerzhinsk, Russian Federation, 606019 Ekaterinburg City Clinical Hospital # 7 | Ekaterinburg, Russian Federation, 620137 S.P. Botkin Moscow City Clinical Hospital | Moscow, Russian Federation, 125284 City Clinical Hospital # 40 | Moscow, Russian Federation, 129301 Nizhniy Novgorod Region Clinical Hospital | Nizny Novgorod, Russian Federation, 603126 Penza Regional Oncology Dispensary | Penza, Russian Federation, 440071 Ryazan Regional Clinical Hospital | Ryazan, Russian Federation, 390039 Saint Petersburg City Hospital #15 | Saint-Petersburg, Russian Federation, 123182 Samara Region Clinical Hospital | Samara, Russian Federation, 443095 Clinical Research Institute of Hematology and Transfusiology | St-Petersburg, Russian Federation, 191024 Oncology Dispensary of Komi Republic | Syktyvkar, Russian Federation, 167904 Hosp. Univ. Germans Trias I Pujol | Badalona, Spain, 08916 Hosp. Clinic de Barcelona | Barcelona, Spain, 08036 Hosp. Univ. Dr. Josep Trueta | Girona, Spain, 17007 Hosp. Univ. Virgen de Las Nieves | Granada, Spain, 18014 Hosp. Univ. de Canarias | La Laguna, Spain, 38320 Hosp. de Leon | Leon, Spain, 24008 Hosp. Gral. Univ. Gregorio Maranon | Madrid, Spain, 28007 Hosp. Univ. Infanta Leonor | Madrid, Spain, 28031 Hosp. Univ. 12 de Octubre | Madrid, Spain, 28041 Clinica Univ. de Navarra | Pamplona, Spain, 31008 Hosp. Quiron Madrid Pozuelo | Pozuelo de Alarcon, Spain, 28223 Hosp. Clinico Univ. de Salamanca | Salamanca, Spain, 37007 Hosp. Univ. Dr. Peset | Valencia, Spain, 46017 Falu Lasarett | Falun, Sweden, 79182 Helsingborgs lasarett | Helsingborg, Sweden, 25187 Karolinska University Hospital, Huddinge | Huddinge, Sweden, 141 86 Skanes universitetssjukhus | Lund, Sweden, 222 41 Norrlands University Hospital | Umea, Sweden, 907 46 Akademiska Sjukhuset | Uppsala, Sweden, SE-751 85 Chang-Hua Christian Hospital | Changhua, Taiwan, 50006 China Medical University Hospital | Taichung City, Taiwan, 40447 Taichung Veterans General Hospital | Taichung,, Taiwan, 40705 National Cheng Kung University Hospital | Tainan, Taiwan, 704 National Taiwan University Hospital | Taipei, Taiwan, 10048 Chang Gung Memorial Hospital | Taoyuan, Taiwan, 33305 Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' | Cherkasy, Ukraine, 18009 Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center | Dnepropetrovsk, Ukraine, 49102 Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk, Ukraine, 76008 SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine | Kharkiv, Ukraine, 61024 National Cancer Institute, Dept. of chemotherapy of hemoblastosis | Kiev, Ukraine, 03022 Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department | Kiev, Ukraine, 03115 State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine' | Kiev, Ukraine, 03115 Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine | Lviv, Ukraine, 79044 Mykolaiv Regional Clinical Hospital | Mykolaiv, Ukraine, 54000 Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital | Poltava, Ukraine, 36011 Blackpool Victoria Hospital | Blackpool, United Kingdom, FY3 8NR Royal Bournemouth Hospital | Bournemouth, United Kingdom, BH7 7DW Leicester Royal Infirmary - Haematology | Leicester, United Kingdom, LE1 5WW St Bartholomew's Hospital | London, United Kingdom, EC1A 7BE Guys St Thomas Hospital | London, United Kingdom, SE1 9RT Christie Hospital NHS Trust | Manchester, United Kingdom, M20 9BX Nottingham City Hospital | Nottingham, United Kingdom, NG5 1PB Royal Marsden Hospital | Surrey, United Kingdom, SM2 5PT New Cross Hospital | Wolverhampton, United Kingdom, WV10 0QP
Investigators

Study Documents (Full Text)

• Documents Provided by Janssen Research & Development, LLC: Study Protocol April 1, 2020
• Documents Provided by Janssen Research & Development, LLC: Statistical Analysis Plan February 12, 2019

More Information

Publications

• Usmani SZ, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis NJ, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Lantz K, O'Rourke L, Heuck C, Delioukina M, Qin X, Nnane I, Qi M, Mateos MV. Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma. Haematologica. 2022 Oct 1;107(10):2408-2417. doi: 10.3324/haematol.2021.279459.

• Iida S, Ishikawa T, Min CK, Kim K, Yeh SP, Usmani SZ, Mateos MV, Nahi H, Heuck C, Qin X, Parasrampuria DA, Gries KS, Qi M, Bahlis N, Ito S. Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study. Ann Hematol. 2021 Apr;100(4):1065-1077. doi: 10.1007/s00277-021-04405-2. Epub 2021 Feb 18.

• Usmani SZ, Mateos MV, Hungria V, Iida S, Bahlis NJ, Nahi H, Magen H, Cavo M, Hulin C, White D, De Stefano V, Fastenau J, Slavcev M, Heuck C, Qin X, Pei H, Masterson T, Lantz K, Gries KS. Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results. J Cancer Res Clin Oncol. 2021 Feb;147(2):619-631. doi: 10.1007/s00432-020-03365-w. Epub 2020 Aug 27.

• Mateos MV, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis N, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Clemens PL, Masterson T, Lantz K, O'Rourke L, Heuck C, Qin X, Parasrampuria DA, Yuan Z, Xu S, Qi M, Usmani SZ. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020 May;7(5):e370-e380. doi: 10.1016/S2352-3026(20)30070-3. Epub 2020 Mar 23. Erratum In: Lancet Haematol. 2020 Oct;7(10):e710. doi: 10.1016/S2352-3026(20)30296-9.

Additional Relevant MeSH Terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Neoplasms by Histologic Type
• Neoplasms
• Hemostatic Disorders
• Vascular Diseases
• Cardiovascular Diseases
• Paraproteinemias
• Blood Protein Disorders
• Hematologic Diseases
• Hemorrhagic Disorders
• Lymphoproliferative Disorders
• Immunoproliferative Disorders
• Immune System Diseases