Approval broadens DAR­ZA­LEX label to in­clude fifth treat­ment op­tion in the re­lapsed / re­frac­tory setting and rep­re­sents the eighth ap­prov­ed in­di­ca­tion for DAR­ZA­LEX

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the U.S. Food and Drug Admin­istra­tion (FDA) ap­prov­al of DAR­ZA­LEX® (dara­tu­mu­mab) in com­bi­na­tion with Kyprolis® (car­filz­o­mib) and dexa­meth­a­sone (DKd) for the treat­ment of adult patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who have re­ceived one to three pre­vi­ous lines of ther­apy. DAR­ZA­LEX® has been ap­prov­ed in com­bi­na­tion with two car­filz­o­mib dosing regi­mens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on pos­i­tive re­­sults from the Phase 3 CANDOR and Phase 1b EQUULEUS stud­ies, rep­re­senting the first-ever ap­prov­al of an anti-CD38 with car­filz­o­mib.

"The sig­nif­i­cant in­crease in pro­gres­sion-free sur­vival (PFS) seen among patients re­ceiv­ing the DKd regi­men sup­ports the use of this new com­bi­na­tion for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. We con­tinue to ad­vance ef­fec­tive regi­mens for the most crit­i­cal patients who have already re­lapsed," said Saad Z. Usmani, M.D., Division Chief of Plasma Cell Disorders, Atrium Health's Levine Cancer In­sti­tute, and prin­ci­pal in­ves­ti­ga­tor of the CANDOR study. "The DKd regi­men fills an im­por­tant gap in the treat­ment landscape, as many patients may relapse fol­low­ing an immuno­modu­la­tory drug-based ther­apy, such as lena­lido­mide-containing regi­mens, and there­fore new thera­peutic op­tions are needed."

The CANDOR study is the first Phase 3 ran­dom­ized trial to compare DKd versus car­filz­o­mib and dexa­meth­a­sone (Kd) in patients with re­lapsed / re­frac­tory mul­ti­ple myeloma. The study, which admin­istered car­filz­o­mib twice weekly, met its pri­mary end­point of PFS after a median follow-up of 16.9 months and 16.3 months for the DKd and Kd arms, re­spec­tively.¹ The median PFS had not been reached in the DKd arm and was 15.8 months in the Kd arm (Hazard Ratio=0.63; 95 per­cent con­fi­dence in­ter­val, 0.46- 0.85; P=0.0014), rep­re­senting a 37 per­cent re­duc­tion in the risk of dis­ease pro­gres­sion or death for patients treated with DKd versus Kd.¹ The inclusion of once-weekly dosing of car­filz­o­mib as an ap­prov­ed DKd regi­men was sup­ported by pos­i­tive re­­sults from the open-label, multi-cohort Phase 1b EQUULEUS trial, which eval­u­ated DAR­ZA­LEX® in com­bi­na­tion with var­i­ous treat­ment regi­mens.²

"With this most recent ap­prov­al of the DKd regi­men, patients with mul­ti­ple myeloma now have the op­tion to re­ceive treat­ment with DAR­ZA­LEX and car­filz­o­mib as early as their first relapse, which is a crit­i­cal time in their treat­ment journey," said Craig Tendler, M.D., Vice Pres­i­dent, Late De­vel­op­ment and Global Medical Affairs, Janssen Re­search & De­vel­op­ment, LLC. "With our deep dis­ease focus and com­mitment to de­vel­op regi­mens which can help im­prove patient out­comes for patients with re­lapsed mul­ti­ple myeloma, the CANDOR study fur­ther estab­lishes another DAR­ZA­LEX-containing regi­men (DKd) which may provide ben­e­fit for this patient pop­u­la­tion."

In CANDOR, the safety profile of DKd was generally con­sis­tent with the known safety profiles of DAR­ZA­LEX® and Kd, and reflect a median treat­ment duration of 16.1 months for the DKd arm and 9.3 months for the Kd arm.¹ Serious ad­verse events (AEs) oc­curred in 56 per­cent and 46 per­cent of patients who re­ceived DKd and Kd, re­spec­tively.¹ The most fre­quent serious AE in the DKd arm, com­pared with the Kd arm, was pneu­monia (14 per­cent vs 9 per­cent). Fatal AEs oc­curred in 10 per­cent of DKd patients and 5 per­cent of Kd patients, and the most fre­quent fatal AE was in­fec­tion (5 per­cent vs 3 per­cent).

About the CANDOR Study¹

CANDOR is a ran­dom­ized, open-label Phase 3 study of DAR­ZA­LEX®, car­filz­o­mib and dexa­meth­a­sone (DKd) com­pared to car­filz­o­mib and dexa­meth­a­sone (Kd) alone. The study eval­u­ated 466 re­lapsed or re­frac­tory patients with mul­ti­ple myeloma who had re­ceived one to three prior lines of ther­apy from 102 global sites. Patients were treated until dis­ease pro­gres­sion. The pri­mary end­point was PFS, and the key sec­ond­ary end­points were over­all re­sponse rate, minimal residual dis­ease and over­all sur­vival. PFS was defined as time from ran­dom­i­za­tion until dis­ease pro­gres­sion or death from any cause.

All patients re­ceived car­filz­o­mib as a 30-minute in­tra­venous (IV) in­fusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 during cycle 1 and 56 mg/m² there­after) and re­ceived 40 mg dexa­meth­a­sone oral or IV weekly (20 mg/m² for patients aged >75 years). In the treat­ment arm, DAR­ZA­LEX® 8 mg/kg was admin­istered IV on days 1 and 2 of cycle 1 and 16 mg/kg IV once weekly for the re­main­ing doses of the first two cycles, then every two weeks for four cycles (cycles 3 to 6), and every four weeks there­after. Of the patients ran­dom­ized in the study, 92 per­cent had re­ceived a prior pro­te­a­some in­hib­i­tor, 42 per­cent had re­ceived prior lena­lido­mide, and 33 per­cent were lena­lido­mide-refractory.¹

CANDOR is an Amgen-sponsored study and is co-funded by Janssen Re­search & De­vel­op­ment, LLC. For more in­for­ma­tion about this trial, please visit www.clinicaltrials.gov under trial identi­fi­ca­tion num­ber NCT03158688.

About the EQUULEUS Study²

EQUULEUS is an open-label, Phase 1b, multi-cohort trial which eval­u­ated the safety, tol­er­a­bil­ity and dosing regi­men of DAR­ZA­LEX®, when admin­istered in com­bi­na­tion with var­i­ous treat­ment regi­mens for the treat­ment of mul­ti­ple myeloma. Among the regi­mens eval­u­ated, the com­bi­na­tion of DAR­ZA­LEX®, car­filz­o­mib and dexa­meth­a­sone (DKd) was studied in 85 patients with re­lapsed / re­frac­tory mul­ti­ple myeloma who had re­ceived at least one to three prior lines of ther­apy. Carfilzomib was eval­u­ated using a once-weekly dosing regi­men, with a start­ing dose of 20 mg/m², which was in­creased to 70 mg/m² on Cycle 1, Day 8 and onward.

About DAR­ZA­LEX®

Janssen is com­mit­ted to exploring the po­ten­tial of DAR­ZA­LEX® (dara­tu­mu­mab) for patients with mul­ti­ple myeloma (MM) across the spectrum of the dis­ease. DAR­ZA­LEX® has been ap­prov­ed in eight in­di­ca­tions, three of which are in the front­line setting, in­clud­ing newly diag­nosed patients with MM who are trans­plant eli­gible and in­eli­gible.

In August 2012, Janssen entered into an ex­clu­sive global license and de­vel­op­ment agree­ment with Genmab A/S to de­vel­op, manu­fac­ture, and com­mer­cial­ize DAR­ZA­LEX®.³ DAR­ZA­LEX® has be­come a back­bone ther­apy in the treat­ment of mul­ti­ple myeloma, having been used in the treat­ment of more than 143,000 patients world­wide and more than 68,000 patients in the U.S. alone since its U.S. FDA ap­prov­al in 2015. DAR­ZA­LEX® is the first CD38-directed anti­body ap­prov­ed globally to treat MM.

CD38 is a surface pro­tein that is present in high num­bers on mul­ti­ple myeloma cells, re­gard­less of the stage of dis­ease.⁴ DAR­ZA­LEX® binds to CD38 and in­hib­its tumor cell growth causing myeloma cell death.⁵ DAR­ZA­LEX® may also have an effect on nor­mal cells.⁵ Data across seven Phase 3 clin­i­cal trials, in both the front­line and re­lapsed settings, have shown that DAR­ZA­LEX®-based regi­mens re­­sulted in sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival and/or over­all sur­vival.^{5,6,7,8,9,10,11,12}

Please see full Prescribing In­for­ma­tion at www.DARZALEX.com.

About Multiple Myeloma

Multiple myeloma is an incurable blood can­cer that affects a type of white blood cell called plasma cells, which are found in the bone mar­row.^13,14 When damaged, these plasma cells rapidly spread and re­place nor­mal cells with tumors in the bone mar­row. In 2020, it is esti­mated that more than 32,000 people will be diag­nosed and close to 13,000 will die from the dis­ease in the U.S.¹⁵ While some patients with mul­ti­ple myeloma have no symp­toms, most patients are diag­nosed due to symp­toms, which can in­clude bone fracture or pain, low red blood cell counts, tiredness, high cal­cium levels, kidney prob­lems or in­fec­tions.¹⁵

DARZALEX® IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

DARZALEX® is con­tra­in­di­cated in patients with a history of severe hypersensitivity (eg, anaphylactic re­ac­tions) to dara­tu­mu­mab or any of the components of the for­mu­la­tion.

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions

DARZALEX® can cause severe and/or serious in­fusion-related re­ac­tions in­clud­ing anaphylactic re­ac­tions. In clin­i­cal trials (monotherapy and com­bi­na­tion: N=2066), in­fusion-related re­ac­tions oc­curred in 37% of patients with the Week 1 (16 mg/kg) in­fusion, 2% with the Week 2 in­fusion, and cumulatively 6% with sub­se­quent in­fusions. Less than 1% of patients had a Grade 3/4 in­fusion-related re­ac­tion at Week 2 or sub­se­quent in­fusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all re­ac­tions oc­curred during in­fusion or within 4 hours of com­plet­ing DAR­ZA­LEX®. Severe re­ac­tions have oc­curred, in­clud­ing bron­cho­spasm, hypoxia, dyspnea, hyper­tension, laryngeal edema, and pul­mo­nary edema. Signs and symp­toms may in­clude res­pira­tory symp­toms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common symp­toms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, and hypo­tension.

When DAR­ZA­LEX® dosing was in­ter­rupted in the setting of ASCT (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DAR­ZA­LEX®, the in­ci­dence of in­fusion-related re­ac­tions was 11% for the first in­fusion fol­low­ing ASCT. Infusion-related re­ac­tions oc­curring at re-initiation of DAR­ZA­LEX® fol­low­ing ASCT were con­sis­tent in terms of symp­toms and se­ver­i­ty (Grade 3 or 4: <1%) with those re­ported in pre­vi­ous stud­ies at Week 2 or sub­se­quent in­fusions. In EQUULEUS, patients re­ceiv­ing com­bi­na­tion treat­ment (n=97) were admin­istered the first 16 mg/kg dose at Week 1 split over two days, ie, 8 mg/kg on Day 1 and Day 2, re­spec­tively. The in­ci­dence of any grade in­fusion-related re­ac­tions was 42%, with 36% of patients experiencing in­fusion-related re­ac­tions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with sub­se­quent in­fusions.

Pre-medicate patients with anti­his­ta­mines, anti­pyretics, and corticosteroids. Frequently monitor patients during the entire in­fusion. Interrupt DAR­ZA­LEX® in­fusion for re­ac­tions of any se­ver­i­ty and in­sti­tute med­i­cal man­age­ment as needed. Permanently dis­con­tinue DAR­ZA­LEX® ther­apy if an anaphylactic re­ac­tion or life-threatening (Grade 4) re­ac­tion oc­curs and in­sti­tute appro­pri­ate emer­gen­cy care. For patients with Grade 1, 2, or 3 re­ac­tions, reduce the in­fusion rate when re-starting the in­fusion.

To reduce the risk of delayed in­fusion-related re­ac­tions, admin­ister oral corticosteroids to all patients fol­low­ing DAR­ZA­LEX® in­fusions. Patients with a history of chronic ob­struc­tive pul­mo­nary dis­ease may re­quire addi­tional post-infusion med­i­ca­tions to man­age res­pira­tory com­pli­ca­tions. Consider pre­scrib­ing short- and long-acting bron­cho­di­lators and inhaled corticosteroids for patients with chronic ob­struc­tive pul­mo­nary dis­ease.

Interference With Serological Testing

Daratumumab binds to CD38 on red blood cells (RBCs) and re­­sults in a pos­i­tive Indirect Antiglobulin Test (Indirect Coombs test). Dara­tu­mu­mab-mediated pos­i­tive Indirect Antiglobulin Test may persist for up to 6 months after the last dara­tu­mu­mab in­fusion. Dara­tu­mu­mab bound to RBCs masks detection of anti­bodies to minor an­ti­gens in the patient's serum. The deter­mi­na­tion of a patient's ABO and Rh blood type is not im­pacted. Notify blood transfusion centers of this inter­fer­ence with serological testing and in­form blood banks that a patient has re­ceived DAR­ZA­LEX®. Type and screen patients prior to start­ing DAR­ZA­LEX®.

Neutropenia and Thrombocytopenia

DARZALEX® may in­crease neu­tro­penia and thrombo­cyto­penia induced by back­ground ther­apy. Monitor com­plete blood cell counts periodically during treat­ment ac­cord­ing to manu­fac­turer's pre­scrib­ing in­for­ma­tion for back­ground ther­a­pies. Monitor patients with neu­tro­penia for signs of in­fec­tion. Consider withholding DAR­ZA­LEX® until re­cov­ery of neu­tro­phils or for re­cov­ery of plate­lets.

Interference With Determination of Complete Re­sponse

Daratumumab is a human IgG kappa mono­clonal anti­body that can be detected on both the serum pro­tein electrophoresis (SPE) and immuno­fix­a­tion (IFE) assays used for the clin­i­cal monitoring of endogenous M-protein. This inter­fer­ence can im­pact the deter­mi­na­tion of com­plete re­sponse and of dis­ease pro­gres­sion in some patients with IgG kappa myeloma pro­tein.

Embryo-Fetal Toxicity

Based on the mech­a­nism of action, DAR­ZA­LEX® can cause fetal harm when admin­istered to a pregnant woman. DAR­ZA­LEX® may cause depletion of fetal im­mune cells and de­creased bone density. Advise pregnant women of the po­ten­tial risk to a fetus. Advise females with reproductive po­ten­tial to use ef­fec­tive con­tra­cep­tion during treat­ment with DAR­ZA­LEX® and for 3 months after the last dose.

The com­bi­na­tion of DAR­ZA­LEX® with lena­lido­mide, poma­lido­mide, or thalido­mide is con­tra­in­di­cated in pregnant women, because lena­lido­mide, poma­lido­mide, and thalido­mide may cause birth defects and death of the unborn child. Refer to the lena­lido­mide, poma­lido­mide, or thalido­mide pre­scrib­ing in­for­ma­tion on use during pregnancy.

ADVERSE REACTIONS

The most fre­quently re­ported ad­verse re­ac­tions (incidence ≥20%) were: upper res­pira­tory in­fec­tion, neu­tro­penia, in­fusion-related re­ac­tions, thrombo­cyto­penia, diarrhea, con­sti­pa­tion, anemia, periph­eral sensory neu­rop­athy, fatigue, periph­eral edema, nausea, cough, pyrexia, dyspnea, and asthenia. The most common hema­to­logic laboratory ab­nor­mal­i­ties (≥40%) with DAR­ZA­LEX® are: neu­tro­penia, lymphopenia, thrombo­cyto­penia, leu­ko­penia, and anemia.

The full Prescribing In­for­ma­tion is avail­able here:

http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf .

About the Janssen Pharma­ceu­tical Com­panies of John­son & John­son

At Janssen, we're creating a future where dis­ease is a thing of the past. We're the Pharma­ceu­tical Com­panies of John­son & John­son, work­ing tirelessly to make that future a reality for patients every­where by fighting sickness with science, im­prov­ing access with ingenuity, and heal­ing hope­less­ness with heart. We focus on areas of med­i­cine where we can make the biggest dif­fer­ence: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Cautions Concerning Forward-Looking State­ments

This press re­lease con­tains "forward-looking state­ments" as defined in the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995 re­gard­ing DAR­ZA­LEX®. The reader is cautioned not to rely on these for­ward-looking state­ments. These state­ments are based on cur­rent ex­pec­ta­tions of future events. If under­lying assump­tions prove inaccurate or known or un­known risks or un­cer­tainties ma­teri­alize, actual re­­sults could vary ma­teri­ally from the ex­pec­ta­tions and pro­jec­tions of Janssen Bio­tech, Inc. and/or John­son & John­son. Risks and un­cer­tainties in­clude, but are not lim­ited to: chal­lenges and un­cer­tainties in­her­ent in prod­uct re­search and de­vel­op­ment, in­clud­ing the un­cer­tainty of clin­i­cal success and of obtaining regu­la­tory ap­prov­als; un­cer­tainty of com­mer­cial success; manu­fac­tur­ing dif­fi­culties and delays; com­pe­ti­tion, in­clud­ing tech­no­log­i­cal ad­vances, new prod­ucts and pat­ents attained by com­pet­i­tors; chal­lenges to pat­ents; prod­uct ef­fi­cacy or safety con­cerns re­­sult­ing in prod­uct recalls or regu­la­tory action; changes in be­havior and spending pat­terns of pur­chasers of health care prod­ucts and services; changes to appli­cable laws and reg­u­la­tions, in­clud­ing global health care reforms; and trends to­ward health care cost con­tainment. A fur­ther list and descriptions of these risks, un­cer­tainties and other factors can be found in John­son & John­son's Annual Report on Form 10-K for the fiscal year ended De­cem­ber 29, 2019, in­clud­ing in the sections cap­tioned "Cautionary Note Regarding Forward-Looking State­ments" and "Item 1A. Risk Factors," and in the com­pany's most recently filed Quar­ter­ly Report on Form 10-Q, and the com­pany's sub­se­quent filings with the Se­cu­ri­ties and Ex­change Com­mis­sion. Copies of these filings are avail­able online at www.sec.gov, www.jnj.com or on re­quest from John­son & John­son. None of the Janssen Pharma­ceu­tical Com­panies nor John­son & John­son un­der­takes to up­date any for­ward-looking state­ment as a re­­sult of new in­for­ma­tion or future events or de­vel­op­ments.

References

1. Saad Z. Usmani, MD et al. Carfilzomib, Dexa­meth­a­sone, and Dara­tu­mu­mab Versus Carfilzomib and Dexa­meth­a­sone for the Treatment of Patients with Re­lapsed or Re­frac­tory Multiple Myeloma (RRMM): Primary Analysis Results from the Randomized, Open-label, Phase 3 Study CANDOR (NCT03158688). 2019 American Society of He­ma­tol­ogy Annual Meeting. De­cem­ber 2019.
2. Janssen Re­search & De­vel­op­ment, LLC. A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Anti­body) in Com­bi­na­tion With Backbone Treatments for the Treatment of Patients With Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT01998971 Identifier: NCT01998971
3. Janssen Bio­tech, Inc. "Janssen Bio­tech Announces Global License and De­vel­op­ment Agreement for Inves­ti­ga­tional Anti-Cancer Agent Dara­tu­mu­mab." Issued August 30, 2012.
4. 2020 Fedele G et al. CD38 Ligation in Peripheral Blood Mononuclear Cells of Myeloma Patients Induces Release of Protumorigenic IL-6 and Impaired Secretion of IFNγ Cytokines and Proliferation. Mediators Inflamm. 2013;564687.
5. Janssen Re­search & De­vel­op­ment, LLC. A Study Comparing Dara­tu­mu­mab, Lena­lido­mide, and Dexa­meth­a­sone With Lena­lido­mide and Dexa­meth­a­sone in Re­lapsed or Re­frac­tory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009?term=mmy3003&rank=1 Identifier: NCT02136134.
6. Janssen Re­search & De­vel­op­ment, LLC. Addi­tion of Dara­tu­mu­mab to Com­bi­na­tion of Bor­tez­o­mib and Dexa­meth­a­sone in Par­tic­i­pants With Re­lapsed or Re­frac­tory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134?term=mmy3004&rank=1 Identifier: NCT02076009.
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8. Janssen Re­search & De­vel­op­ment, LLC. A Study of Com­bi­na­tion of Dara­tu­mu­mab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Par­tic­i­pants With Previously Untreated Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479?term=mmy3007&rank=1 Identifier: NCT02195479.
9. Janssen Re­search & De­vel­op­ment, LLC. Study Comparing Dara­tu­mu­mab, Lena­lido­mide, and Dexa­meth­a­sone With Lena­lido­mide and Dexa­meth­a­sone in Par­tic­i­pants With Previously Untreated Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172?term=mmy3008&rank=1 Identifier: NCT02252172.
10. Janssen Re­search & De­vel­op­ment, LLC. A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Dara­tu­mu­mab in Com­bi­na­tion With VMP (D-VMP), in Par­tic­i­pants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812?term=MMY3011&rank=1 Identifier: NCT03217812.
11. Euro­pean Myeloma Network. Compare Progression Free Survival Btw Dara­tu­mu­mab/Pomalidomide/Dexamethasone vs Poma­lido­mide/Dexamethasone (EMN14). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03180736?term=MMY3013&rank=2 Identifier: NCT03180736
12. Amgen. Study of Carfilzomib, Dara­tu­mu­mab and Dexa­meth­a­sone for Patients With Re­lapsed and/or Re­frac­tory Multiple Myeloma. (CANDOR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03158688?term=NCT03158688&rank=1 Identifier: NCT03158688.
13. Kumar, SK et al. Risk of pro­gres­sion and sur­vival in mul­ti­ple myeloma relapsing after ther­apy with IMiDs and bor­tez­o­mib: a multi­center inter­na­tional myeloma work­ing group study. Leukemia. 2012 Jan; 26(1):149-57.
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Source: Janssen.