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CompletedNCT02136134Updated Aug 29, 2025Results posted

Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3 interventional study of Daratumumab and VELCADE (Bortezomib) in Multiple Myeloma, sponsored by Janssen Research & Development, LLC. Completed at 105 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
498
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.

Read the detailed description

This is an open-label (physicians and participants know the identity of the assigned treatment), randomized (the study medication is assigned by chance), multicenter, active-controlled study comparing daratumumab, VELCADE, and dexamethasone (DVd) with VELCADE and dexamethasone (Vd) in participants with relapsed or refractory multiple myeloma. Approximately 480 participants will be randomly assigned in a 1:1 ratio to receive either DVd or Vd. Randomization will be stratified by International Staging System (ISS), number of prior treatment programs (1 vs. 2 or 3 vs. >3), and prior VELCADE treatment ("no" vs. "yes"). Within each stratum, participants will be randomized to one of the treatment groups.The study will consist of a Screening Phase, a Treatment Phase, and a Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity, or other reasons to discontinue the study.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
  • Plasmacytoma
  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Daratumumab
  • VELCADE
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Must have had documented multiple myeloma
  • Must have received at least 1 prior line of therapy for multiple myeloma
  • Must have had documented evidence of progressive disease as defined based on Investigator's determination of response of International Myeloma Working Group (IMWG) criteria on or after their last regimen
  • Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
  • Must have achieved a response (partial response [PR] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen in the past

Exclusion criteria

Exclusion Criteria:

  • Has received daratumumab or other anti-CD38 therapies previously
  • Is refractory to VELCADE or another PI, like ixazomib and carfilzomib (had progression of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy or another PI therapy, like ixazomib and carfilzomib
  • Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE treatment)
  • Has 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 milligram per day [mg/day] for a maximum of 4 days) before treatment. A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the Site Investigational Product Procedures Manual (IPPM).
  • Has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization
  • Has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
498 participants (actual)

Study arms

  • Experimental
    Daratumumab+VELCADE+dexamethasone

    Daratumumab, VELCADE and dexamethasone

    Drug: Daratumumab · Drug: VELCADE (Bortezomib) · Drug: Dexamethasone

  • Active comparator
    VELCADE+dexamethasone

    VELCADE and dexamethasone.

    Drug: VELCADE (Bortezomib) · Drug: Dexamethasone

Interventions

  • DrugDaratumumab

    Daratumumab will be administered as an IV infusion or 16 mg/kg weekly for the first 3 cycles, on Day 1 of Cycles 4-9, and then every 4 weeks thereafter. As per protocol amendment-6 participants receiving treatment with daratumumab IV will have the option to switch to daratumumab SC 1800 mg on Day 1 of any cycle, at the discretion of the investigator.

  • DrugVELCADE (Bortezomib)

    VELCADE will be administered at a dose of 1.3 mg/m2 subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle. Eight VELCADE treatment cycles are to be administered.

    Also known as: VELCADE

  • DrugDexamethasone

    Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 VELCADE treatment cycles.

05

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS)

    PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (\>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 gram per deciliter (g/dL); Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be \>10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new 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.

    Time frame: From the date of randomization to either progressive disease or death, whichever occurred first (approximately 1 year 4 months)

Secondary outcomes

  1. Time to Disease Progression (TTP)

    TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of \>=25% in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 g/dL; Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be \>10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.

    Time frame: From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurred first (approximately 6 years 9 months)

  2. Percentage of Participants With a Very Good Partial Response (VGPR) or Better

    Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the 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% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of \>90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.

    Time frame: Up to disease progression (approximately 6 years 9 months)

  3. Overall Response Rate (ORR)

    The Overall response rate was defined as the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: \>=50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by \>=90% or to \<200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required.

    Time frame: Up to disease progression (approximately 6 years 9 months)

  4. Percentage of Participants With Negative Minimal Residual Disease (MRD)

    The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR plus normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.

    Time frame: Up to disease progression (approximately 6 years 9 months)

  5. Overall Survival (OS)

    Overall Survival was measured from the date of randomization to the date of the participant's death.

    Time frame: Up to 6 years 9 months

06

Results

Posted Feb 10, 2017

Participant flow

Participant flow — Overall Study
MilestoneBortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)
Started247251
Daratumumab monotherapy870
Completed00
Not completed247251
Withdrew: Death170148
Withdrew: Withdrawal by subject1910
Withdrew: Lost to follow-up33
Withdrew: Uspecified5590

Outcome measures

PrimaryProgression-free Survival (PFS)

PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (\>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 gram per deciliter (g/dL); Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be \>10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new 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.

Time frame:
From the date of randomization to either progressive disease or death, whichever occurred first (approximately 1 year 4 months)
Reported as:
Median · months
Progression-free Survival (PFS)
monthsBortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)
Progression-free Survival (PFS)7.16 (6.21 to 7.85)NA (12.25 to NA)
SecondaryTime to Disease Progression (TTP)

TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of \>=25% in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 g/dL; Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be \>10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.

Time frame:
From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurred first (approximately 6 years 9 months)
Reported as:
Median · months
Time to Disease Progression (TTP)
monthsBortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)
Time to Disease Progression (TTP)7.29 (6.41 to 8.08)NA (12.25 to NA)
SecondaryPercentage of Participants With a Very Good Partial Response (VGPR) or Better

Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the 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% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of \>90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.

Time frame:
Up to disease progression (approximately 6 years 9 months)
Reported as:
Number · percentage of participants
Percentage of Participants With a Very Good Partial Response (VGPR) or Better
percentage of participantsBortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)
Percentage of Participants With a Very Good Partial Response (VGPR) or Better29.1 (23.3 to 35.3)59.2 (52.7 to 65.4)
SecondaryOverall Response Rate (ORR)

The Overall response rate was defined as the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: \>=50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by \>=90% or to \<200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required.

Time frame:
Up to disease progression (approximately 6 years 9 months)
Reported as:
Number · percentage of participants
Overall Response Rate (ORR)
percentage of participantsBortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)
Overall Response Rate (ORR)63.2 (56.7 to 69.4)82.9 (77.5 to 87.5)
SecondaryPercentage of Participants With Negative Minimal Residual Disease (MRD)

The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR plus normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.

Time frame:
Up to disease progression (approximately 6 years 9 months)
Reported as:
Number · percentage of participants
Percentage of Participants With Negative Minimal Residual Disease (MRD)
percentage of participantsBortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)
Percentage of Participants With Negative Minimal Residual Disease (MRD)2.813.5
SecondaryOverall Survival (OS)

Overall Survival was measured from the date of randomization to the date of the participant's death.

Time frame:
Up to 6 years 9 months
Reported as:
Median · months
Overall Survival (OS)
monthsBortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)
Overall Survival (OS)38.51 (31.18 to 46.23)49.58 (42.18 to 62.32)

Adverse events

Collected over Up to 6 years 9 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bortezomib + Dexamethasone (Vd)—81/237 (34.2%)217/237 (91.6%)
Daratumumab + Bortezomib and Dexamethasone (DVd)—134/243 (55.1%)238/243 (97.9%)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy—7/87 (8%)29/87 (33.3%)
Most frequent serious events
Showing 10 of 197
Most frequent serious events
EventBortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
PneumoniaInfections and infestations24/23726/2430/87
AnaemiaBlood and lymphatic system disorders1/2379/2431/87
PyrexiaGeneral disorders4/2377/2431/87
BronchitisInfections and infestations2/2377/2430/87
ThrombocytopeniaBlood and lymphatic system disorders1/2376/2431/87
Atrial fibrillationCardiac disorders0/2376/2430/87
Upper respiratory tract infectionInfections and infestations2/2376/2430/87
DiarrhoeaGastrointestinal disorders0/2374/2430/87
SepsisInfections and infestations2/2374/2430/87
Bone painMusculoskeletal and connective tissue disorders1/2374/2430/87
Most frequent other events
Showing 10 of 57
Most frequent other events
EventBortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
ThrombocytopeniaBlood and lymphatic system disorders105/237145/2430/87
Peripheral sensory neuropathyNervous system disorders90/237122/2430/87
DiarrhoeaGastrointestinal disorders53/23788/2430/87
Upper respiratory tract infectionInfections and infestations41/23788/2431/87
AnaemiaBlood and lymphatic system disorders75/23768/2431/87
CoughRespiratory, thoracic and mediastinal disorders30/23771/2433/87
FatigueGeneral disorders58/23757/2430/87
ConstipationGastrointestinal disorders37/23756/2430/87
Back painMusculoskeletal and connective tissue disorders24/23752/2432/87
Oedema peripheralGeneral disorders20/23748/2430/87

Baseline characteristics

Age, Continuous
Age, Continuous(years)Bortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)Total
Mean63.9 ± 9.8162.8 ± 9.6663.4 ± 9.74
Sex: Female, Male
Sex: Female, Male(Participants)Bortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)Total
Female99114213
Male148137285
Region of Enrollment
Region of Enrollment(participants)Bortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)Total
Australia202343
Brazil91322
Czech Republic191635
Germany212142
Hungary141630
Italy252449
Korea, Republic of81018
Mexico123
Netherlands141125
Poland181634
Russian Federation132134
Spain191029
Sweden91019
Turkey141428
Ukraine222850
United States211637
Stage of Disease (ISS)
Stage of Disease (ISS)(participants)Bortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)Total
I9698194
II10094194
III5159110
No. of Prior Lines of Therapy
No. of Prior Lines of Therapy(participants)Bortezomib + Dexamethasone (Vd)Daratumumab + Bortezomib and Dexamethasone (DVd)Total
1113122235
27470144
3323769
>3282250
07

Study locations

105 sites
  • Birmingham, Alabama, United States
  • Los Angeles, California, United States
  • Stamford, Connecticut, United States
  • Jacksonville, Florida, United States
  • Atlanta, Georgia, United States
  • Niles, Illinois, United States
  • Topeka, Kansas, United States
  • Westwood, Kansas, United States
  • Marrero, Louisiana, United States
  • Boston, Massachusetts, United States
  • Lansing, Michigan, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • Seattle, Washington, United States
  • Adelaide, Australia
  • Concord, Australia
  • Fitzroy, Australia
  • Hobart, Australia
  • Melbourne, Australia
  • Nedlands, Australia
  • Woodville South, Australia
  • Barretos, Brazil
  • Porto Alegre, Brazil
  • Salvador, Brazil
  • São Paulo, Brazil
  • Brno, Czechia
  • Hradec Králové, Czechia
  • Ostrava-Poruba, Czechia
  • Prague, Czechia
  • Bamberg, Germany
  • Berlin, Germany
  • Düsseldorf, Germany
  • Freiburg im Breisgau, Germany
  • Göttingen, Germany
  • Hamburg, Germany
  • Mainz, Germany
  • München, Germany
  • Stuttgart, Germany
  • Tübingen, Germany
  • Ulm, Germany
  • Würzburg, Germany
  • Budapest, Hungary
  • Debrecen, Hungary
  • Győr, Hungary
  • Pécs, Hungary
  • Veszprém, Hungary
  • Huixquilucan, Mexico
  • Monterrey, Mexico
  • Alkmaar, Netherlands
  • Amersfoort, Netherlands
  • Dordrecht, Netherlands
  • Groningen, Netherlands
  • Leiden, Netherlands
  • Maastricht, Netherlands
  • Nijmegen, Netherlands
  • The Hague, Netherlands
  • Chorzów, Poland
  • Katowice, Poland
  • Krakow, Poland
  • Poznan, Poland
  • Warsaw, Poland
  • Krasnodar, Russia
  • Moscow, Russia
  • Nizhny Novgorod, Russia
  • Penza, Russia
  • Pyatigorsk, Russia
  • Ryazan, Russia
  • Samara, Russia
  • Sochi, Russia
  • Syktyvkar, Russia
  • Busan, South Korea
  • Hwasun, South Korea
  • Seoul, South Korea
  • Suwon, South Korea
  • Ulsan, South Korea
  • Madrid, Spain
  • Salamanca, Spain
  • San Sebastián de los Reyes, Spain
  • Toledo, Spain
  • Valencia, Spain
  • Linköping, Sweden
  • Luleå, Sweden
  • Lund, Sweden
  • Örebro, Sweden
  • Sundsvall, Sweden
  • Umeå, Sweden
  • Uppsala, Sweden
  • Västerås, Sweden
  • Ankara, Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
  • Izmir, Turkey (Türkiye)
  • Kayseri, Turkey (Türkiye)
  • Kocaeli, Turkey (Türkiye)
  • Malatya, Turkey (Türkiye)
  • Cherkasy, Ukraine
  • Dnipro, Ukraine
  • Ivano-Frankivsk, Ukraine

Showing the first 100 of 105 sites across 15 countries.

08

References and documents

Publications

  • Almansour SA, Alqudah MAY, Abuhelwa Z, Al-Shamsi HO, Alhuraiji A, Semreen MH, Bustanji Y, Alzoubi KH, Modi ND, Mckinnon RA, Sorich MJ, Hopkins AM, Abuhelwa AY. Antithrombotic utilization, adverse events, and associations with treatment outcomes in multiple myeloma: pooled analysis of three clinical trials. Ther Adv Med Oncol. 2024 Sep 2;16:17588359241275387. doi: 10.1177/17588359241275387. eCollection 2024. PubMed 39229471 ↗
  • Spencer A, Moreau P, Mateos MV, Goldschmidt H, Suzuki K, Levin MD, Sonneveld P, Orlowski RZ, Yoon SS, Usmani SZ, Weisel K, Reece D, Ahmadi T, Pei H, Mayo WG, Gai X, Carey J, Bartlett JB, Carson R, Dimopoulos MA. Daratumumab for patients with myeloma with early or late relapse after initial therapy: subgroup analysis of CASTOR and POLLUX. Blood Adv. 2024 Jan 23;8(2):388-398. doi: 10.1182/bloodadvances.2023010579. PubMed 38048391 ↗
  • Sonneveld P, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, Spicka I, Hungria V, Munder M, Mateos MV, Mark TM, Levin MD, Ahmadi T, Qin X, Garvin Mayo W, Gai X, Carey J, Carson R, Spencer A. Overall Survival With Daratumumab, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma (CASTOR): A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2023 Mar 10;41(8):1600-1609. doi: 10.1200/JCO.21.02734. Epub 2022 Nov 22. PubMed 36413710 ↗
  • He J, Berringer H, Heeg B, Ruan H, Kampfenkel T, Dwarakanathan HR, Johnston S, Mendes J, Lam A, Bathija S, Mackay EK. Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma. Adv Ther. 2022 Sep;39(9):4230-4249. doi: 10.1007/s12325-022-02226-x. Epub 2022 Jul 22. PubMed 35876974 ↗
  • Cavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101. PubMed 34289038 ↗
  • Avet-Loiseau H, San-Miguel J, Casneuf T, Iida S, Lonial S, Usmani SZ, Spencer A, Moreau P, Plesner T, Weisel K, Ukropec J, Chiu C, Trivedi S, Amin H, Krevvata M, Ramaswami P, Qin X, Qi M, Sun S, Qi M, Kobos R, Bahlis NJ. Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR. J Clin Oncol. 2021 Apr 1;39(10):1139-1149. doi: 10.1200/JCO.20.01814. Epub 2021 Jan 29. PubMed 33513030 ↗
  • Weisel K, Spencer A, Lentzsch S, Avet-Loiseau H, Mark TM, Spicka I, Masszi T, Lauri B, Levin MD, Bosi A, Hungria V, Cavo M, Lee JJ, Nooka A, Quach H, Munder M, Lee C, Barreto W, Corradini P, Min CK, Chanan-Khan AA, Horvath N, Capra M, Beksac M, Ovilla R, Jo JC, Shin HJ, Sonneveld P, Casneuf T, DeAngelis N, Amin H, Ukropec J, Kobos R, Mateos MV. Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk. J Hematol Oncol. 2020 Aug 20;13(1):115. doi: 10.1186/s13045-020-00948-5. PubMed 32819447 ↗
  • Mateos MV, Spencer A, Nooka AK, Pour L, Weisel K, Cavo M, Laubach JP, Cook G, Iida S, Benboubker L, Usmani SZ, Yoon SS, Bahlis NJ, Chiu C, Ukropec J, Schecter JM, Qin X, O'Rourke L, Dimopoulos MA. Daratumumab-based regimens are highly effective and well tolerated in relapsed or refractory multiple myeloma regardless of patient age: subgroup analysis of the phase 3 CASTOR and POLLUX studies. Haematologica. 2020 Jan 31;105(2):468-477. doi: 10.3324/haematol.2019.217448. Print 2020. PubMed 31221782 ↗
  • Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, Spicka I, Hungria V, Munder M, Mateos MV, Mark TM, Qi M, Schecter J, Amin H, Qin X, Deraedt W, Ahmadi T, Spencer A, Sonneveld P; CASTOR Investigators. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Aug 25;375(8):754-66. doi: 10.1056/NEJMoa1606038. PubMed 27557302 ↗
09

Registry details

Key details

Study ID
NCT02136134
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
May 12, 2014
Start date
Aug 15, 2014
Primary completion
Jan 11, 2016
Completion
Jan 10, 2024
Results posted
Feb 10, 2017
Last update
Aug 29, 2025

Study contacts

Janssen Research & Development, LLC Clinical trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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