A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma
Objective We evaluated ibrutinib, a once‐daily inhibitor of Bruton's tyrosine kinase, combined with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who had received 1‐3 prior therapies. Methods This was a phase 2, single‐arm, open‐label, multicentr...
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| Veröffentlicht in: | European journal of haematology 2020-05, Vol.104 (5), p.435-442 |
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| creator | Hajek, Roman Pour, Ludek Ozcan, Muhit Martin Sánchez, Jesus García Sanz, Ramon Anagnostopoulos, Achilles Oriol, Albert Cascavilla, Nicola Terjung, Andreas Lee, Yihua Briso, Eva M. Dobkowska, Edyta Hauns, Bernhard Špička, Ivan |
| description | Objective
We evaluated ibrutinib, a once‐daily inhibitor of Bruton's tyrosine kinase, combined with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who had received 1‐3 prior therapies.
Methods
This was a phase 2, single‐arm, open‐label, multicentre study (NCT02902965). The primary endpoint was progression‐free survival (PFS).
Results
Seventy‐six patients were enrolled; 74 received ≥1 dose of study treatment. After median follow‐up of 19.6 months, median PFS was 8.5 months (95% CI: 6.2‐10.8); median overall survival was not reached. Overall response rate was 57% (95% CI: 45‐68), and median duration of response was 9.5 months (95% CI: 6.9‐10.6). Grade 3/4 AEs occurred in 73% of patients and fatal AEs occurred in 15% of patients. Incidence of major haemorrhage was 5%; one patient died from cerebral haemorrhage. After an observed increased incidence of serious (42%) and fatal (11%) infections, enrolment was suspended to implement risk‐minimisation measures. The safety profile was otherwise consistent with known safety profiles of the individual drugs.
Conclusion
Ibrutinib combined with bortezomib and dexamethasone elicited clinical responses. However, efficacy assessments conducted at potential restart of enrolment indicated that the targeted PFS could not be reached with additional patient enrolment, and the study was terminated. |
| doi_str_mv | 10.1111/ejh.13377 |
| format | Article |
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We evaluated ibrutinib, a once‐daily inhibitor of Bruton's tyrosine kinase, combined with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who had received 1‐3 prior therapies.
Methods
This was a phase 2, single‐arm, open‐label, multicentre study (NCT02902965). The primary endpoint was progression‐free survival (PFS).
Results
Seventy‐six patients were enrolled; 74 received ≥1 dose of study treatment. After median follow‐up of 19.6 months, median PFS was 8.5 months (95% CI: 6.2‐10.8); median overall survival was not reached. Overall response rate was 57% (95% CI: 45‐68), and median duration of response was 9.5 months (95% CI: 6.9‐10.6). Grade 3/4 AEs occurred in 73% of patients and fatal AEs occurred in 15% of patients. Incidence of major haemorrhage was 5%; one patient died from cerebral haemorrhage. After an observed increased incidence of serious (42%) and fatal (11%) infections, enrolment was suspended to implement risk‐minimisation measures. The safety profile was otherwise consistent with known safety profiles of the individual drugs.
Conclusion
Ibrutinib combined with bortezomib and dexamethasone elicited clinical responses. However, efficacy assessments conducted at potential restart of enrolment indicated that the targeted PFS could not be reached with additional patient enrolment, and the study was terminated.</description><identifier>ISSN: 0902-4441</identifier><identifier>EISSN: 1600-0609</identifier><identifier>DOI: 10.1111/ejh.13377</identifier><identifier>PMID: 31883396</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adenine - administration & dosage ; Adenine - analogs & derivatives ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Bortezomib ; Bortezomib - administration & dosage ; Bruton's tyrosine kinase ; Dexamethasone ; Dexamethasone - administration & dosage ; Drug Resistance, Neoplasm ; Enzyme inhibitors ; Female ; Hemorrhage ; Humans ; ibrutinib ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Multiple myeloma ; Multiple Myeloma - diagnosis ; Multiple Myeloma - drug therapy ; Multiple Myeloma - mortality ; Neoplasm Staging ; Original ; Patients ; Piperidines - administration & dosage ; Prognosis ; Protein-tyrosine kinase ; Recurrence ; Retreatment ; Survival ; Treatment Outcome</subject><ispartof>European journal of haematology, 2020-05, Vol.104 (5), p.435-442</ispartof><rights>2019 The Authors. Published by John Wiley & Sons Ltd</rights><rights>2019 The Authors. European Journal of Haematology Published by John Wiley & Sons Ltd.</rights><rights>2019. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4437-e5d2e03d11dfea3b81689024b691ca7718dde8658cfe7c4e8572d2046558ce0f3</citedby><cites>FETCH-LOGICAL-c4437-e5d2e03d11dfea3b81689024b691ca7718dde8658cfe7c4e8572d2046558ce0f3</cites><orcidid>0000-0001-6955-6267</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fejh.13377$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fejh.13377$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,1416,27922,27923,45572,45573</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31883396$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hajek, Roman</creatorcontrib><creatorcontrib>Pour, Ludek</creatorcontrib><creatorcontrib>Ozcan, Muhit</creatorcontrib><creatorcontrib>Martin Sánchez, Jesus</creatorcontrib><creatorcontrib>García Sanz, Ramon</creatorcontrib><creatorcontrib>Anagnostopoulos, Achilles</creatorcontrib><creatorcontrib>Oriol, Albert</creatorcontrib><creatorcontrib>Cascavilla, Nicola</creatorcontrib><creatorcontrib>Terjung, Andreas</creatorcontrib><creatorcontrib>Lee, Yihua</creatorcontrib><creatorcontrib>Briso, Eva M.</creatorcontrib><creatorcontrib>Dobkowska, Edyta</creatorcontrib><creatorcontrib>Hauns, Bernhard</creatorcontrib><creatorcontrib>Špička, Ivan</creatorcontrib><title>A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma</title><title>European journal of haematology</title><addtitle>Eur J Haematol</addtitle><description>Objective
We evaluated ibrutinib, a once‐daily inhibitor of Bruton's tyrosine kinase, combined with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who had received 1‐3 prior therapies.
Methods
This was a phase 2, single‐arm, open‐label, multicentre study (NCT02902965). The primary endpoint was progression‐free survival (PFS).
Results
Seventy‐six patients were enrolled; 74 received ≥1 dose of study treatment. After median follow‐up of 19.6 months, median PFS was 8.5 months (95% CI: 6.2‐10.8); median overall survival was not reached. Overall response rate was 57% (95% CI: 45‐68), and median duration of response was 9.5 months (95% CI: 6.9‐10.6). Grade 3/4 AEs occurred in 73% of patients and fatal AEs occurred in 15% of patients. Incidence of major haemorrhage was 5%; one patient died from cerebral haemorrhage. After an observed increased incidence of serious (42%) and fatal (11%) infections, enrolment was suspended to implement risk‐minimisation measures. The safety profile was otherwise consistent with known safety profiles of the individual drugs.
Conclusion
Ibrutinib combined with bortezomib and dexamethasone elicited clinical responses. However, efficacy assessments conducted at potential restart of enrolment indicated that the targeted PFS could not be reached with additional patient enrolment, and the study was terminated.</description><subject>Adenine - administration & dosage</subject><subject>Adenine - analogs & derivatives</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Bortezomib</subject><subject>Bortezomib - administration & dosage</subject><subject>Bruton's tyrosine kinase</subject><subject>Dexamethasone</subject><subject>Dexamethasone - administration & dosage</subject><subject>Drug Resistance, Neoplasm</subject><subject>Enzyme inhibitors</subject><subject>Female</subject><subject>Hemorrhage</subject><subject>Humans</subject><subject>ibrutinib</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multiple myeloma</subject><subject>Multiple Myeloma - diagnosis</subject><subject>Multiple Myeloma - drug therapy</subject><subject>Multiple Myeloma - mortality</subject><subject>Neoplasm Staging</subject><subject>Original</subject><subject>Patients</subject><subject>Piperidines - administration & dosage</subject><subject>Prognosis</subject><subject>Protein-tyrosine kinase</subject><subject>Recurrence</subject><subject>Retreatment</subject><subject>Survival</subject><subject>Treatment Outcome</subject><issn>0902-4441</issn><issn>1600-0609</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kc1u1TAQRi1ERW8LC16gstQVi_T6L3GyqVRVpQVVYgNry4knXF8ldmo7LWHLi-OSUtEF3ljyHJ-Z0YfQe0rOaD5b2O_OKOdSvkIbWhFSkIo0r9GGNIQVQgh6iI5i3BNCWEPlG3TIaV1z3lQb9OsCTzsdATMc02wW7Hts2zAn62yLrcOdH1vrdLLe4Qebdrj1IcFPP-aydgYb-KFHSNnhHTx-mDILLsWVDjDoKYLZBuiD7pIPCx7nIdlpADwuMPhRv0UHvR4ivHu6j9G3j1dfL2-K2y_Xny4vbotOCC4LKA0Dwg2lpgfN25pWdV5QtFVDOy0lrY2BuirrrgfZCahLyQwjoirzE5CeH6Pz1TvN7Qimy1MGPagp2FGHRXlt1cuKszv13d8ryXIrzrPg9EkQ_N0MMam9n4PLMyvGGyKZJKLM1IeV6oKPMe_93IES9ZiXynmpP3ll9uTfkZ7JvwFlYLsCD3aA5f8mdfX5ZlX-BpR1ouA</recordid><startdate>202005</startdate><enddate>202005</enddate><creator>Hajek, Roman</creator><creator>Pour, Ludek</creator><creator>Ozcan, Muhit</creator><creator>Martin Sánchez, Jesus</creator><creator>García Sanz, Ramon</creator><creator>Anagnostopoulos, Achilles</creator><creator>Oriol, Albert</creator><creator>Cascavilla, Nicola</creator><creator>Terjung, Andreas</creator><creator>Lee, Yihua</creator><creator>Briso, Eva M.</creator><creator>Dobkowska, Edyta</creator><creator>Hauns, Bernhard</creator><creator>Špička, Ivan</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QG</scope><scope>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>H94</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6955-6267</orcidid></search><sort><creationdate>202005</creationdate><title>A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma</title><author>Hajek, Roman ; Pour, Ludek ; Ozcan, Muhit ; Martin Sánchez, Jesus ; García Sanz, Ramon ; Anagnostopoulos, Achilles ; Oriol, Albert ; Cascavilla, Nicola ; Terjung, Andreas ; Lee, Yihua ; Briso, Eva M. ; Dobkowska, Edyta ; Hauns, Bernhard ; Špička, Ivan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4437-e5d2e03d11dfea3b81689024b691ca7718dde8658cfe7c4e8572d2046558ce0f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adenine - administration & dosage</topic><topic>Adenine - analogs & derivatives</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Bortezomib</topic><topic>Bortezomib - administration & dosage</topic><topic>Bruton's tyrosine kinase</topic><topic>Dexamethasone</topic><topic>Dexamethasone - administration & dosage</topic><topic>Drug Resistance, Neoplasm</topic><topic>Enzyme inhibitors</topic><topic>Female</topic><topic>Hemorrhage</topic><topic>Humans</topic><topic>ibrutinib</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multiple myeloma</topic><topic>Multiple Myeloma - diagnosis</topic><topic>Multiple Myeloma - drug therapy</topic><topic>Multiple Myeloma - mortality</topic><topic>Neoplasm Staging</topic><topic>Original</topic><topic>Patients</topic><topic>Piperidines - administration & dosage</topic><topic>Prognosis</topic><topic>Protein-tyrosine kinase</topic><topic>Recurrence</topic><topic>Retreatment</topic><topic>Survival</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hajek, Roman</creatorcontrib><creatorcontrib>Pour, Ludek</creatorcontrib><creatorcontrib>Ozcan, Muhit</creatorcontrib><creatorcontrib>Martin Sánchez, Jesus</creatorcontrib><creatorcontrib>García Sanz, Ramon</creatorcontrib><creatorcontrib>Anagnostopoulos, Achilles</creatorcontrib><creatorcontrib>Oriol, Albert</creatorcontrib><creatorcontrib>Cascavilla, Nicola</creatorcontrib><creatorcontrib>Terjung, Andreas</creatorcontrib><creatorcontrib>Lee, Yihua</creatorcontrib><creatorcontrib>Briso, Eva M.</creatorcontrib><creatorcontrib>Dobkowska, Edyta</creatorcontrib><creatorcontrib>Hauns, Bernhard</creatorcontrib><creatorcontrib>Špička, Ivan</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Animal Behavior Abstracts</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European journal of haematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hajek, Roman</au><au>Pour, Ludek</au><au>Ozcan, Muhit</au><au>Martin Sánchez, Jesus</au><au>García Sanz, Ramon</au><au>Anagnostopoulos, Achilles</au><au>Oriol, Albert</au><au>Cascavilla, Nicola</au><au>Terjung, Andreas</au><au>Lee, Yihua</au><au>Briso, Eva M.</au><au>Dobkowska, Edyta</au><au>Hauns, Bernhard</au><au>Špička, Ivan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma</atitle><jtitle>European journal of haematology</jtitle><addtitle>Eur J Haematol</addtitle><date>2020-05</date><risdate>2020</risdate><volume>104</volume><issue>5</issue><spage>435</spage><epage>442</epage><pages>435-442</pages><issn>0902-4441</issn><eissn>1600-0609</eissn><abstract>Objective
We evaluated ibrutinib, a once‐daily inhibitor of Bruton's tyrosine kinase, combined with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who had received 1‐3 prior therapies.
Methods
This was a phase 2, single‐arm, open‐label, multicentre study (NCT02902965). The primary endpoint was progression‐free survival (PFS).
Results
Seventy‐six patients were enrolled; 74 received ≥1 dose of study treatment. After median follow‐up of 19.6 months, median PFS was 8.5 months (95% CI: 6.2‐10.8); median overall survival was not reached. Overall response rate was 57% (95% CI: 45‐68), and median duration of response was 9.5 months (95% CI: 6.9‐10.6). Grade 3/4 AEs occurred in 73% of patients and fatal AEs occurred in 15% of patients. Incidence of major haemorrhage was 5%; one patient died from cerebral haemorrhage. After an observed increased incidence of serious (42%) and fatal (11%) infections, enrolment was suspended to implement risk‐minimisation measures. The safety profile was otherwise consistent with known safety profiles of the individual drugs.
Conclusion
Ibrutinib combined with bortezomib and dexamethasone elicited clinical responses. However, efficacy assessments conducted at potential restart of enrolment indicated that the targeted PFS could not be reached with additional patient enrolment, and the study was terminated.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>31883396</pmid><doi>10.1111/ejh.13377</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-6955-6267</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | European journal of haematology, 2020-05, Vol.104 (5), p.435-442 |
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| subjects | Adenine - administration & dosage Adenine - analogs & derivatives Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bortezomib Bortezomib - administration & dosage Bruton's tyrosine kinase Dexamethasone Dexamethasone - administration & dosage Drug Resistance, Neoplasm Enzyme inhibitors Female Hemorrhage Humans ibrutinib Kaplan-Meier Estimate Male Middle Aged Multiple myeloma Multiple Myeloma - diagnosis Multiple Myeloma - drug therapy Multiple Myeloma - mortality Neoplasm Staging Original Patients Piperidines - administration & dosage Prognosis Protein-tyrosine kinase Recurrence Retreatment Survival Treatment Outcome |
| title | A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma |
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