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DREAMM 7: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04246047
Collaborator
(none)
575
Enrollment
150
Locations
2
Arms
73.4
Anticipated Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Approximately 478 participants will be randomized 1:1 to Arm A (B-Vd) or Arm B (D-Vd). Treatment will continue in both arms until progressive disease, death, unacceptable toxicity, withdrawal of consent or end of study, whichever occurs first.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
575 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
This is an open-label study; therefore, no blinding of treatment identity is needed.
Primary Purpose:
Treatment
Official Title:
DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date :
May 7, 2020
Anticipated Primary Completion Date :
Apr 21, 2023
Anticipated Study Completion Date :
Jun 19, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)

Drug: Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate

Drug: Bortezomib
Proteasome Inhibitor

Drug: Dexamethasone
Synthetic glucocorticoid with anti-tumor activity
Active Comparator: Daratumumab and Bortezomib plus Dexamethasone (Arm B)

Drug: Daratumumab
Anti-cluster of differentiation 38 [CD-38] monoclonal antibody

Drug: Bortezomib
Proteasome Inhibitor

Drug: Dexamethasone
Synthetic glucocorticoid with anti-tumor activity

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [Up to an average of 34 months]

    Time from start of study treatment to the first documented disease progression or death due to any cause, whichever occurs first.

Secondary Outcome Measures

  1. Complete response rate (CRR) [Up to 74 months]

    Percentage of participants with a confirmed complete response or better.

  2. Overall response rate (ORR) [Up to 74 months]

    Percentage of participants with a confirmed partial response or better.

  3. Duration of response (DoR) after administration of study treatment [Up to 74 months]

    Time from first documented evidence of partial response or better to date of first documented progression or death, whichever occurs first.

  4. Time to response (TTR) after administration of study treatment [Up to 74 months]

    Time from the start of study treatment to the first documented evidence of response among participants who achieve partial response or better.

  5. Time to Progression (TTP) after administration of study treatment [Up to 74 months]

    Time from the start of study treatment until the first documented date of disease progression or death, whichever occurs first.

  6. Overall survival (OS) [Up to 74 months]

    Time from randomization to death due to any cause.

  7. Progression-free survival on subsequent line of therapy (PFS2) [Up to 74 months]

    Time from start of study treatment to disease progression after initiation of new anti-cancer therapy or death from any cause, whichever occurs first.

  8. Minimal Residual Disease (MRD) negativity rate after administration of study treatment [Up to 74 months]

    Percentage of participants who are MRD negative by next-generation sequencing.

  9. Number of participants with adverse events (AEs) [Up to 74 months]

    AEs will be collected, including abnormal laboratory parameters.

  10. Number of participants with serious adverse events (SAEs) [Up to 74 months]

    SAEs will be collected.

  11. Number of participants with abnormal ocular findings on ophthalmic examination [Up to 74 months]

    Ophthalmic examination will assess abnormal findings.

  12. Plasma concentrations of belantamab mafodotin at indicated time points [Up to 74 months]

    Plasma concentrations of belantamab mafodotin in Arm A.

  13. Plasma concentrations of total monoclonal antibody (mAb) at indicated time points [Up to 74 months]

    Plasma concentrations of total mAb in Arm A.

  14. Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points [Up to 74 months]

    Plasma concentrations of cys-mcMMAF in Arm A.

  15. Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin [Up to 74 months]

    Plasma concentrations of belantamab mafodotin ADAs in Arm A.

  16. Titers of ADAs against belantamab mafodotin [Up to 74 months]

    Titers of ADAs in Arm A.

  17. Change from Baseline in symptoms as measured by Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) [Baseline and Up to 74 months]

    PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score.

  18. Change from Baseline in impacts as measured by PRO-CTCAE [Baseline and Up to 74 months]

    PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trial. Impacts of the side effects will be assessed using PRO-CTCAE score.

  19. Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30) [Baseline and Up to 74 months]

    EORTC Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.

  20. Change from Baseline in HRQoL as measured by EORTC, 20-Item Multiple Myeloma Module (QLQ-MY20) [Baseline and Up to 74 months]

    EORTC 20-item Multiple Myeloma Module QLQ-MY20 questionnaire: only Disease Symptoms Domain will be administered. A high score represents a high level of symptoms or problems.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.

  • Previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

  • Must have at least 1 aspect of measurable disease, defined as one of the following;

  1. Urine M-protein excretion >=200 mg per 24-hour, or

  2. Serum M-protein concentration >=0.5 grams per deciliter (g/dL), or

  3. Serum free light chain (FLC) assay: involved FLC level >=10 mg per dL (>=100 mg per liter) and an abnormal serum free light chain ratio (<0.26 or >1.65).

  • All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be <=Grade 1 at the time of enrollment, except for alopecia.

  • Adequate organ function

Exclusion Criteria:

  • Intolerant to daratumumab.

  • Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment).

  • Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed.

  • Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.

  • Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.

  • Prior allogenic stem cell transplant.

  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.

  • Corneal epithelial disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Yuma Arizona United States 85364
2 GSK Investigational Site Denver Colorado United States 80218
3 GSK Investigational Site Westwood Kansas United States 66205
4 GSK Investigational Site Cincinnati Ohio United States 45242
5 GSK Investigational Site Tyler Texas United States 75702
6 GSK Investigational Site Roanoke Virginia United States 24014
7 GSK Investigational Site Camperdown New South Wales Australia 2050
8 GSK Investigational Site Liverpool New South Wales Australia 2170
9 GSK Investigational Site St Leonards New South Wales Australia 2065
10 GSK Investigational Site Waratah New South Wales Australia 2298
11 GSK Investigational Site Wollongong New South Wales Australia 2500
12 GSK Investigational Site Benowa Queensland Australia 4217
13 GSK Investigational Site Herston Queensland Australia 4029
14 GSK Investigational Site Kurralta Park South Australia Australia 5037
15 GSK Investigational Site Box Hill Victoria Australia 3128
16 GSK Investigational Site Heidelberg Victoria Australia 3084
17 GSK Investigational Site Melbourne Victoria Australia 3004
18 GSK Investigational Site Murdoch Western Australia Australia 6150
19 GSK Investigational Site Nedlands Western Australia Australia 6009
20 GSK Investigational Site Brussel Belgium 1090
21 GSK Investigational Site Bruxelles Belgium 1200
22 GSK Investigational Site Gent Belgium 9000
23 GSK Investigational Site Roeselare Belgium 8800
24 GSK Investigational Site Natal Rio Grande Do Norte Brazil 59075-740
25 GSK Investigational Site Porto Alegre Rio Grande Do Sul Brazil 90035-903
26 GSK Investigational Site Florianopolis Santa Catarina Brazil 88034-000
27 GSK Investigational Site Joinville Santa Catarina Brazil 89201-260
28 GSK Investigational Site Rio de Janeiro Brazil 22793-080
29 GSK Investigational Site São Paulo Brazil 04537-080
30 GSK Investigational Site São Paulo Brazil 05403-000
31 GSK Investigational Site Edmonton Alberta Canada T6G 1Z2
32 GSK Investigational Site London Ontario Canada N6A 5W9
33 GSK Investigational Site Québec Ontario Canada G1J 1Z4
34 GSK Investigational Site Toronto Ontario Canada M4N 3M5
35 GSK Investigational Site Montréal Quebec Canada H4J 1C5
36 GSK Investigational Site Guangzhou Guangdong China 510060
37 GSK Investigational Site Nanjing Jiangsu China 210008
38 GSK Investigational Site Changchun Jilin China 130012
39 GSK Investigational Site Jianan Shandong China 250012
40 GSK Investigational Site Hangzhou Zhejiang China 310003
41 GSK Investigational Site Beijing China 100020
42 GSK Investigational Site Beijing China 100191
43 GSK Investigational Site GuangZhou China 510515
44 GSK Investigational Site Jiang Su Province China 215006
45 GSK Investigational Site Shenyang China 110001
46 GSK Investigational Site Tianjin China 300020
47 GSK Investigational Site Tianjin China 300052
48 GSK Investigational Site Wuhan China 430022
49 GSK Investigational Site Zhengzhou China 450052
50 GSK Investigational Site Brno Czechia 625 00
51 GSK Investigational Site Hradec Kralove Czechia 500 05
52 GSK Investigational Site Ostrava Czechia 708 52
53 GSK Investigational Site Praha 2 Czechia 128 08
54 GSK Investigational Site Amiens cedex 1 France 80054
55 GSK Investigational Site Caen cedex 9 France 14033
56 GSK Investigational Site Nice France 06200
57 GSK Investigational Site Paris cedex 13 France 75651
58 GSK Investigational Site Rennes cedex 9 France 35033
59 GSK Investigational Site Ulm Baden-Wuerttemberg Germany 89081
60 GSK Investigational Site Muenchen Bayern Germany 81377
61 GSK Investigational Site Wuerzburg Bayern Germany 97080
62 GSK Investigational Site Duesseldorf Nordrhein-Westfalen Germany 40225
63 GSK Investigational Site Koeln Nordrhein-Westfalen Germany 50937
64 GSK Investigational Site Jena Thueringen Germany 07747
65 GSK Investigational Site Alexandroupolis Greece 68 100
66 GSK Investigational Site Athens Greece 11528
67 GSK Investigational Site Thessaloniki Greece 54007
68 GSK Investigational Site Jerusalem Israel 91120
69 GSK Investigational Site Kfar Saba Israel 44281
70 GSK Investigational Site Tel Aviv Israel 64239
71 GSK Investigational Site Tel Hashomer Israel 52621
72 GSK Investigational Site Bologna Emilia-Romagna Italy 40138
73 GSK Investigational Site Meldola Emilia-Romagna Italy 47014
74 GSK Investigational Site Ravenna Emilia-Romagna Italy 48123
75 GSK Investigational Site Roma Lazio Italy 00168
76 GSK Investigational Site Bergamo Lombardia Italy 24127
77 GSK Investigational Site Brescia Lombardia Italy 25123
78 GSK Investigational Site Milano Lombardia Italy 20133
79 GSK Investigational Site Torino Piemonte Italy 10126
80 GSK Investigational Site Catania Sicilia Italy 95123
81 GSK Investigational Site Siena Toscana Italy 53100
82 GSK Investigational Site Aichi Japan 441-8570
83 GSK Investigational Site Aichi Japan 446-8602
84 GSK Investigational Site Aichi Japan 467-8602
85 GSK Investigational Site Aomori Japan 030-8553
86 GSK Investigational Site Chiba Japan 296-8602
87 GSK Investigational Site Ehime Japan 790-8524
88 GSK Investigational Site Fukuoka Japan 806-8501
89 GSK Investigational Site Fukuoka Japan 807-8555
90 GSK Investigational Site Fukuoka Japan 810-8563
91 GSK Investigational Site Fukushima Japan 960-1295
92 GSK Investigational Site Gifu Japan 503-8502
93 GSK Investigational Site Gunma Japan 377-0280
94 GSK Investigational Site Hokkaido Japan 060-8648
95 GSK Investigational Site Hyogo Japan 650-0047
96 GSK Investigational Site Hyogo Japan 670-8540
97 GSK Investigational Site Kanagawa Japan 221-0855
98 GSK Investigational Site Kanagawa Japan 247-8533
99 GSK Investigational Site Kyoto Japan 602-8566
100 GSK Investigational Site Nagano Japan 392-8510
101 GSK Investigational Site Okayama Japan 701-1192
102 GSK Investigational Site Osaka Japan 530-0012
103 GSK Investigational Site Osaka Japan 545-8586
104 GSK Investigational Site Shizuoka Japan 411-8777
105 GSK Investigational Site Tokyo Japan 141-8625
106 GSK Investigational Site Busan Korea, Republic of 49241
107 GSK Investigational Site Seongnam-si, Gyeonggi-do Korea, Republic of 13620
108 GSK Investigational Site Seoul Korea, Republic of 06351
109 GSK Investigational Site Seoul Korea, Republic of 06591
110 GSK Investigational Site Ulsan Korea, Republic of 44033
111 GSK Investigational Site Dordrecht Netherlands 3318 AT
112 GSK Investigational Site Groningen Netherlands 9713 GZ
113 GSK Investigational Site Auckland New Zealand 622
114 GSK Investigational Site Christchurch New Zealand 8011
115 GSK Investigational Site Dunedin New Zealand 9054
116 GSK Investigational Site Newtown New Zealand 6021
117 GSK Investigational Site Chorzow Poland 41-500
118 GSK Investigational Site Krakow Poland 30510
119 GSK Investigational Site Lodz Poland 93-513
120 GSK Investigational Site Lublin Poland 20-081
121 GSK Investigational Site Lublin Poland 20-090
122 GSK Investigational Site Nowy Sacz Poland 33-300
123 GSK Investigational Site Poznan Poland 60-569
124 GSK Investigational Site Warszawa Poland 02-781
125 GSK Investigational Site Moscow Russian Federation 125284
126 GSK Investigational Site Nizhniy Novgorod Russian Federation 603126
127 GSK Investigational Site Novosibirsk Russian Federation 630087
128 GSK Investigational Site Samara Russian Federation 443021
129 GSK Investigational Site Saratov Russian Federation 410028
130 GSK Investigational Site St'Petersburg Russian Federation 191024
131 GSK Investigational Site St. Petersburg Russian Federation 197 089
132 GSK Investigational Site Ufa Russian Federation 450083
133 GSK Investigational Site Badalona Spain 08916
134 GSK Investigational Site Barcelona Spain 08035
135 GSK Investigational Site Cáceres Spain 10003
136 GSK Investigational Site Gijón Spain 33394
137 GSK Investigational Site Hospitalet de Llobregat (Barcelona) Spain 08908
138 GSK Investigational Site Madrid Spain 28007
139 GSK Investigational Site Murcia Spain 30008
140 GSK Investigational Site Móstoles Spain 28933
141 GSK Investigational Site Pamplona Spain 31008
142 GSK Investigational Site Pozuelo De Alarcón/Madrid Spain 28223
143 GSK Investigational Site Salamanca Spain 37007
144 GSK Investigational Site Stoke-on-Trent Staffordshire United Kingdom ST4 6QG
145 GSK Investigational Site Sutton Surrey United Kingdom SM2 5PT
146 GSK Investigational Site Bournemouth United Kingdom BH7 7DW
147 GSK Investigational Site Cardiff United Kingdom CF14 4XW
148 GSK Investigational Site Dundee United Kingdom DD1 9SY
149 GSK Investigational Site Leicester United Kingdom LE1 5WW
150 GSK Investigational Site London United Kingdom W12 0NN

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT04246047
Other Study ID Numbers:
  • 207503
First Posted:
Jan 29, 2020
Last Update Posted:
Jul 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GlaxoSmithKline
Belantamab mafodotin
Relapsed/refractory multiple myeloma
Daratumumab
Bortezomib
Dexamethasone
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Bortezomib
Daratumumab

Study Results

No Results Posted as of Jul 6, 2022