A phase 1 clinical trial evaluating marizomib, pomalidomide and low‐dose dexamethasone in relapsed and refractory multiple myeloma (NPI‐0052‐107): final study results
Summary Marizomib (MRZ) is an irreversible, pan‐subunit proteasome inhibitor (PI) in clinical development for relapsed/refractory multiple myeloma (RRMM) and glioma. This study analysed MRZ, pomalidomide (POM) and low‐dose dexamethasone (Lo‐DEX) [PMD] in RRMM to evaluate safety and determine the max...
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| Veröffentlicht in: | British journal of haematology 2018-01, Vol.180 (1), p.41-51 |
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| creator | Spencer, Andrew Harrison, Simon Zonder, Jeffrey Badros, Ashraf Laubach, Jacob Bergin, Krystal Khot, Amit Zimmerman, Todd Chauhan, Dharminder Levin, Nancy MacLaren, Ann Reich, Steven D. Trikha, Mohit Richardson, Paul |
| description | Summary
Marizomib (MRZ) is an irreversible, pan‐subunit proteasome inhibitor (PI) in clinical development for relapsed/refractory multiple myeloma (RRMM) and glioma. This study analysed MRZ, pomalidomide (POM) and low‐dose dexamethasone (Lo‐DEX) [PMD] in RRMM to evaluate safety and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Intravenous MRZ (0·3–0·5 mg/m2) was administered over 2 h on days 1, 4, 8, 11; POM (3–4 mg) on days 1–21; and Lo‐DEX (5 or 10 mg) on days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22 and 23 of every 28‐day cycle. Thirty‐eight patients were enrolled that had received a median of 4 (range 1–10) prior lines of therapy; all patients received prior lenalidomide and bortezomib. No dose‐limiting toxicities (DLTs) were observed and 0·5 mg/m2 MRZ was determined to be the RP2D. The most common treatment‐related ≥Grade 3 adverse events were: neutropenia (11/38 patients: 29%), pneumonia (4/38 patients 11%), anaemia (4/38 patients; 11%) and thrombocytopenia (4/38 patients; 11%). The overall response rate and clinical benefit rate was 53% (19/36) and 64% (23/36), respectively. In conclusion, PMD was well tolerated and demonstrated promising activity in heavily pre‐treated, high‐risk RRMM patients. |
| doi_str_mv | 10.1111/bjh.14987 |
| format | Article |
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Marizomib (MRZ) is an irreversible, pan‐subunit proteasome inhibitor (PI) in clinical development for relapsed/refractory multiple myeloma (RRMM) and glioma. This study analysed MRZ, pomalidomide (POM) and low‐dose dexamethasone (Lo‐DEX) [PMD] in RRMM to evaluate safety and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Intravenous MRZ (0·3–0·5 mg/m2) was administered over 2 h on days 1, 4, 8, 11; POM (3–4 mg) on days 1–21; and Lo‐DEX (5 or 10 mg) on days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22 and 23 of every 28‐day cycle. Thirty‐eight patients were enrolled that had received a median of 4 (range 1–10) prior lines of therapy; all patients received prior lenalidomide and bortezomib. No dose‐limiting toxicities (DLTs) were observed and 0·5 mg/m2 MRZ was determined to be the RP2D. The most common treatment‐related ≥Grade 3 adverse events were: neutropenia (11/38 patients: 29%), pneumonia (4/38 patients 11%), anaemia (4/38 patients; 11%) and thrombocytopenia (4/38 patients; 11%). The overall response rate and clinical benefit rate was 53% (19/36) and 64% (23/36), respectively. In conclusion, PMD was well tolerated and demonstrated promising activity in heavily pre‐treated, high‐risk RRMM patients.</description><identifier>ISSN: 0007-1048</identifier><identifier>ISSN: 1365-2141</identifier><identifier>EISSN: 1365-2141</identifier><identifier>DOI: 10.1111/bjh.14987</identifier><identifier>PMID: 29076150</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Bortezomib ; Brain tumors ; Clinical trials ; Dexamethasone ; Dexamethasone - administration & dosage ; Dexamethasone - pharmacokinetics ; Drug Resistance, Neoplasm ; Female ; Glioma ; Hematology ; Humans ; Intravenous administration ; Lactones - administration & dosage ; Lactones - pharmacokinetics ; low‐dose dexamethasone ; Male ; marizomib ; Middle Aged ; Multiple myeloma ; Multiple Myeloma - drug therapy ; Multiple Myeloma - mortality ; Multiple Myeloma - pathology ; Neutropenia ; pomalidomide ; proteasome inhibitor ; Proteasomes ; Pyrroles - administration & dosage ; Pyrroles - pharmacokinetics ; Recurrence ; relapsed/refractory multiple myeloma ; Retreatment ; Survival Analysis ; Thalidomide - administration & dosage ; Thalidomide - analogs & derivatives ; Thalidomide - pharmacokinetics ; Thrombocytopenia ; Toxicity ; Treatment Outcome</subject><ispartof>British journal of haematology, 2018-01, Vol.180 (1), p.41-51</ispartof><rights>2017 John Wiley & Sons Ltd</rights><rights>2017 John Wiley & Sons Ltd.</rights><rights>Copyright © 2018 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4437-779f238032944df8cd263f1d888fa09e74505f24a5d5650fbba16a45e58f25773</citedby><cites>FETCH-LOGICAL-c4437-779f238032944df8cd263f1d888fa09e74505f24a5d5650fbba16a45e58f25773</cites><orcidid>0000-0002-5638-9954 ; 0000-0002-7426-8865 ; 0000-0001-7565-2052</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%2Fbjh.14987$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjh.14987$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,315,781,785,886,1418,1434,27929,27930,45579,45580,46414,46838</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29076150$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Spencer, Andrew</creatorcontrib><creatorcontrib>Harrison, Simon</creatorcontrib><creatorcontrib>Zonder, Jeffrey</creatorcontrib><creatorcontrib>Badros, Ashraf</creatorcontrib><creatorcontrib>Laubach, Jacob</creatorcontrib><creatorcontrib>Bergin, Krystal</creatorcontrib><creatorcontrib>Khot, Amit</creatorcontrib><creatorcontrib>Zimmerman, Todd</creatorcontrib><creatorcontrib>Chauhan, Dharminder</creatorcontrib><creatorcontrib>Levin, Nancy</creatorcontrib><creatorcontrib>MacLaren, Ann</creatorcontrib><creatorcontrib>Reich, Steven D.</creatorcontrib><creatorcontrib>Trikha, Mohit</creatorcontrib><creatorcontrib>Richardson, Paul</creatorcontrib><title>A phase 1 clinical trial evaluating marizomib, pomalidomide and low‐dose dexamethasone in relapsed and refractory multiple myeloma (NPI‐0052‐107): final study results</title><title>British journal of haematology</title><addtitle>Br J Haematol</addtitle><description>Summary
Marizomib (MRZ) is an irreversible, pan‐subunit proteasome inhibitor (PI) in clinical development for relapsed/refractory multiple myeloma (RRMM) and glioma. This study analysed MRZ, pomalidomide (POM) and low‐dose dexamethasone (Lo‐DEX) [PMD] in RRMM to evaluate safety and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Intravenous MRZ (0·3–0·5 mg/m2) was administered over 2 h on days 1, 4, 8, 11; POM (3–4 mg) on days 1–21; and Lo‐DEX (5 or 10 mg) on days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22 and 23 of every 28‐day cycle. Thirty‐eight patients were enrolled that had received a median of 4 (range 1–10) prior lines of therapy; all patients received prior lenalidomide and bortezomib. No dose‐limiting toxicities (DLTs) were observed and 0·5 mg/m2 MRZ was determined to be the RP2D. The most common treatment‐related ≥Grade 3 adverse events were: neutropenia (11/38 patients: 29%), pneumonia (4/38 patients 11%), anaemia (4/38 patients; 11%) and thrombocytopenia (4/38 patients; 11%). The overall response rate and clinical benefit rate was 53% (19/36) and 64% (23/36), respectively. In conclusion, PMD was well tolerated and demonstrated promising activity in heavily pre‐treated, high‐risk RRMM patients.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Bortezomib</subject><subject>Brain tumors</subject><subject>Clinical trials</subject><subject>Dexamethasone</subject><subject>Dexamethasone - administration & dosage</subject><subject>Dexamethasone - pharmacokinetics</subject><subject>Drug Resistance, Neoplasm</subject><subject>Female</subject><subject>Glioma</subject><subject>Hematology</subject><subject>Humans</subject><subject>Intravenous administration</subject><subject>Lactones - administration & dosage</subject><subject>Lactones - pharmacokinetics</subject><subject>low‐dose dexamethasone</subject><subject>Male</subject><subject>marizomib</subject><subject>Middle Aged</subject><subject>Multiple myeloma</subject><subject>Multiple Myeloma - drug therapy</subject><subject>Multiple Myeloma - mortality</subject><subject>Multiple Myeloma - pathology</subject><subject>Neutropenia</subject><subject>pomalidomide</subject><subject>proteasome inhibitor</subject><subject>Proteasomes</subject><subject>Pyrroles - administration & dosage</subject><subject>Pyrroles - pharmacokinetics</subject><subject>Recurrence</subject><subject>relapsed/refractory multiple myeloma</subject><subject>Retreatment</subject><subject>Survival Analysis</subject><subject>Thalidomide - administration & dosage</subject><subject>Thalidomide - analogs & derivatives</subject><subject>Thalidomide - pharmacokinetics</subject><subject>Thrombocytopenia</subject><subject>Toxicity</subject><subject>Treatment Outcome</subject><issn>0007-1048</issn><issn>1365-2141</issn><issn>1365-2141</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kkFu1TAQQC0Eop_CggsgS2xaibTjxI4dFkilAlpUAQtYW05s9_vLiYOdtIQVR-AgnIqT4PaXCpDwwiPLb57G40HoMYEDktdhu1kfENoIfgetSFWzoiSU3EUrAOAFASp20IOUNgCkAkbuo52yAV4TBiv04wiPa5UMJrjzbnCd8niKLu_mQvlZTW44x72K7mvoXfsMj6FX3ul80AarQWMfLn9--65DVmjzRfVmyrowGOwGHI1XYzL6GozGRtVNIS64n_3kRm9wvxifhXjv3YfTbAFgZQ4E-P5zbN2Qq0jTrJecm3JKeojuWeWTeXQTd9Gn168-Hp8UZ-_fnB4fnRUdpRUvOG9sWQmoyoZSbUWny7qyRAshrILGcMqA2ZIqplnNwLatIrWizDBhS8Z5tYtebL3j3PZGd2aYovJyjC53YpFBOfn3zeDW8jxcyFrUUNU0C_ZuBDF8nk2aZO9SZ7xXgwlzkqRhnHLCGMvo03_QTZhjfvoVJaBuKOOQqf0t1cWQUm7lbTEE5NUMyDwD8noGMvvkz-pvyd-fnoHDLXDpvFn-b5Iv355slb8AIyC_ig</recordid><startdate>201801</startdate><enddate>201801</enddate><creator>Spencer, Andrew</creator><creator>Harrison, Simon</creator><creator>Zonder, Jeffrey</creator><creator>Badros, Ashraf</creator><creator>Laubach, Jacob</creator><creator>Bergin, Krystal</creator><creator>Khot, Amit</creator><creator>Zimmerman, Todd</creator><creator>Chauhan, Dharminder</creator><creator>Levin, Nancy</creator><creator>MacLaren, Ann</creator><creator>Reich, Steven D.</creator><creator>Trikha, Mohit</creator><creator>Richardson, Paul</creator><general>Blackwell Publishing Ltd</general><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>7T5</scope><scope>H94</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-5638-9954</orcidid><orcidid>https://orcid.org/0000-0002-7426-8865</orcidid><orcidid>https://orcid.org/0000-0001-7565-2052</orcidid></search><sort><creationdate>201801</creationdate><title>A phase 1 clinical trial evaluating marizomib, pomalidomide and low‐dose dexamethasone in relapsed and refractory multiple myeloma (NPI‐0052‐107): final study results</title><author>Spencer, Andrew ; Harrison, Simon ; Zonder, Jeffrey ; Badros, Ashraf ; Laubach, Jacob ; Bergin, Krystal ; Khot, Amit ; Zimmerman, Todd ; Chauhan, Dharminder ; Levin, Nancy ; MacLaren, Ann ; Reich, Steven D. ; Trikha, Mohit ; Richardson, Paul</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4437-779f238032944df8cd263f1d888fa09e74505f24a5d5650fbba16a45e58f25773</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Bortezomib</topic><topic>Brain tumors</topic><topic>Clinical trials</topic><topic>Dexamethasone</topic><topic>Dexamethasone - administration & dosage</topic><topic>Dexamethasone - pharmacokinetics</topic><topic>Drug Resistance, Neoplasm</topic><topic>Female</topic><topic>Glioma</topic><topic>Hematology</topic><topic>Humans</topic><topic>Intravenous administration</topic><topic>Lactones - administration & dosage</topic><topic>Lactones - pharmacokinetics</topic><topic>low‐dose dexamethasone</topic><topic>Male</topic><topic>marizomib</topic><topic>Middle Aged</topic><topic>Multiple myeloma</topic><topic>Multiple Myeloma - drug therapy</topic><topic>Multiple Myeloma - mortality</topic><topic>Multiple Myeloma - pathology</topic><topic>Neutropenia</topic><topic>pomalidomide</topic><topic>proteasome inhibitor</topic><topic>Proteasomes</topic><topic>Pyrroles - administration & dosage</topic><topic>Pyrroles - pharmacokinetics</topic><topic>Recurrence</topic><topic>relapsed/refractory multiple myeloma</topic><topic>Retreatment</topic><topic>Survival Analysis</topic><topic>Thalidomide - administration & dosage</topic><topic>Thalidomide - analogs & derivatives</topic><topic>Thalidomide - pharmacokinetics</topic><topic>Thrombocytopenia</topic><topic>Toxicity</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Spencer, Andrew</creatorcontrib><creatorcontrib>Harrison, Simon</creatorcontrib><creatorcontrib>Zonder, Jeffrey</creatorcontrib><creatorcontrib>Badros, Ashraf</creatorcontrib><creatorcontrib>Laubach, Jacob</creatorcontrib><creatorcontrib>Bergin, Krystal</creatorcontrib><creatorcontrib>Khot, Amit</creatorcontrib><creatorcontrib>Zimmerman, Todd</creatorcontrib><creatorcontrib>Chauhan, Dharminder</creatorcontrib><creatorcontrib>Levin, Nancy</creatorcontrib><creatorcontrib>MacLaren, Ann</creatorcontrib><creatorcontrib>Reich, Steven D.</creatorcontrib><creatorcontrib>Trikha, Mohit</creatorcontrib><creatorcontrib>Richardson, Paul</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of haematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Spencer, Andrew</au><au>Harrison, Simon</au><au>Zonder, Jeffrey</au><au>Badros, Ashraf</au><au>Laubach, Jacob</au><au>Bergin, Krystal</au><au>Khot, Amit</au><au>Zimmerman, Todd</au><au>Chauhan, Dharminder</au><au>Levin, Nancy</au><au>MacLaren, Ann</au><au>Reich, Steven D.</au><au>Trikha, Mohit</au><au>Richardson, Paul</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase 1 clinical trial evaluating marizomib, pomalidomide and low‐dose dexamethasone in relapsed and refractory multiple myeloma (NPI‐0052‐107): final study results</atitle><jtitle>British journal of haematology</jtitle><addtitle>Br J Haematol</addtitle><date>2018-01</date><risdate>2018</risdate><volume>180</volume><issue>1</issue><spage>41</spage><epage>51</epage><pages>41-51</pages><issn>0007-1048</issn><issn>1365-2141</issn><eissn>1365-2141</eissn><abstract>Summary
Marizomib (MRZ) is an irreversible, pan‐subunit proteasome inhibitor (PI) in clinical development for relapsed/refractory multiple myeloma (RRMM) and glioma. This study analysed MRZ, pomalidomide (POM) and low‐dose dexamethasone (Lo‐DEX) [PMD] in RRMM to evaluate safety and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Intravenous MRZ (0·3–0·5 mg/m2) was administered over 2 h on days 1, 4, 8, 11; POM (3–4 mg) on days 1–21; and Lo‐DEX (5 or 10 mg) on days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22 and 23 of every 28‐day cycle. Thirty‐eight patients were enrolled that had received a median of 4 (range 1–10) prior lines of therapy; all patients received prior lenalidomide and bortezomib. No dose‐limiting toxicities (DLTs) were observed and 0·5 mg/m2 MRZ was determined to be the RP2D. The most common treatment‐related ≥Grade 3 adverse events were: neutropenia (11/38 patients: 29%), pneumonia (4/38 patients 11%), anaemia (4/38 patients; 11%) and thrombocytopenia (4/38 patients; 11%). The overall response rate and clinical benefit rate was 53% (19/36) and 64% (23/36), respectively. In conclusion, PMD was well tolerated and demonstrated promising activity in heavily pre‐treated, high‐risk RRMM patients.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>29076150</pmid><doi>10.1111/bjh.14987</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-5638-9954</orcidid><orcidid>https://orcid.org/0000-0002-7426-8865</orcidid><orcidid>https://orcid.org/0000-0001-7565-2052</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bortezomib Brain tumors Clinical trials Dexamethasone Dexamethasone - administration & dosage Dexamethasone - pharmacokinetics Drug Resistance, Neoplasm Female Glioma Hematology Humans Intravenous administration Lactones - administration & dosage Lactones - pharmacokinetics low‐dose dexamethasone Male marizomib Middle Aged Multiple myeloma Multiple Myeloma - drug therapy Multiple Myeloma - mortality Multiple Myeloma - pathology Neutropenia pomalidomide proteasome inhibitor Proteasomes Pyrroles - administration & dosage Pyrroles - pharmacokinetics Recurrence relapsed/refractory multiple myeloma Retreatment Survival Analysis Thalidomide - administration & dosage Thalidomide - analogs & derivatives Thalidomide - pharmacokinetics Thrombocytopenia Toxicity Treatment Outcome |
| title | A phase 1 clinical trial evaluating marizomib, pomalidomide and low‐dose dexamethasone in relapsed and refractory multiple myeloma (NPI‐0052‐107): final study results |
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