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JOURNAL ONKOLOGIE – STUDIE
DREAMM 9

Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma

Rekrutierend

NCT-Nummer:
NCT04091126

Studienbeginn:
Dezember 2019

Letztes Update:
25.07.2022

Wirkstoff:
Belantamab mafodotin, Bortezomib, Lenalidomide, Dexamethasone

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
GlaxoSmithKline

Collaborator:
-

Studienleiter

GSK Clinical Trials
Study Director
GlaxoSmithKline

Kontakt

EU GSK Clinical Trials Call Center
Kontakt:
Phone: +44 (0) 20 89904466
E-Mail: GSKClinicalSupportHD@gsk.com» Kontaktdaten anzeigen

Studienlocations
(3 von 35)

GSK Investigational Site
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
19049 Schwerin
(Mecklenburg-Vorpommern)
GermanyAbgeschlossen» Google-Maps
GSK Investigational Site
56068 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
85364 Yuma
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
66205 Westwood
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
28204 Charlotte
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
53792 Madison
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
2298 Waratah
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
3065 Fitzroy
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
86021 Poitiers cedex
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
40138 Bologna
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
47014 Meldola
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
00161 Roma
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
137-701 Seoul, Korea
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
20-081 Lublin
PolandRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
61-848 Poznan
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Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
08916 Badalona
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
08036 Barcelona
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
28027 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
29010 Málaga
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
31008 Pamplona
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
28223 Pozuelo De Alarcón/Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
39008 Santander
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
SO16 6YD Southampton
United KingdomAbgeschlossen» Google-Maps
GSK Investigational Site
OX3 7LE Headington, Oxford
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
LE1 5WW Leicester
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
SE1 9RT London
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity

of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide),

dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants

with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of

bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by

the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per

dosing schedule. Participants will receive belantamab mafodotin on a schedule that is

dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered

in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to

Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every

12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the

point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after

EOT.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participant must be over 18 years of age inclusive, at the time of signing the

informed consent.

- Diagnosis of multiple myeloma with a requirement for treatment as documented per

international myeloma working group (IMWG) criteria.

- Must have at least one aspect of measurable disease, defined as one of the following:

- Urine M-protein excretion >=200 mg/24 hours (>=0.2 gram [g]/24 hours), or

- Serum M-protein concentration >=0.5 grams per deciliter (g/dL) (>=5.0 gram per liter

[g/L]), or

- Serum free light chain (FLC) assay: involved FLC level >=10 milligrams per deciliter

(mg/dL) (>=100 milligram per liter [mg/L]) and an abnormal serum free light chain

ratio (<0.26 or >1.65).

- Not a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT)

due to presence of significant comorbid condition(s), such as cardiac, pulmonary or

other major organ dysfunction that are likely to have a negative impact on

tolerability of high dose chemotherapy with stem cell transplantation, as judged by

the investigator.

- Eastern cooperative oncology group (ECOG) status of 0-2

- Adequate organ system functions as defined by the laboratory assessments listed as

following: Absolute neutrophil count (ANC) >=1.5 x 10^9/L; Hemoglobin >=8.0 g/dL;

Platelets >=75 x 10^9/L; Total bilirubin <=1.5 x upper limit of normal (ULN);

(Isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct

bilirubin is <35%); Alanine aminotransferase (ALT) <=2.5 x ULN; eGFR >=30

mL/minute/1.73 meter^2; Urine Dipstick for protein OR Albumin/creatinine ratio (from

spot urine)- Negative/trace (if >=1 plus only eligible if confirmed <=500 mg/gram (56

mg/millimoles [mmol]) by albumin/creatinine ratio (spot urine from first void); Left

Ventricular Ejection Fraction (LVEF) by echocardiogram (ECHO) of >=35% participants

with low LVEF (per institutional standards), consider referring to cardiology per

local standards of care.

- Sex and Contraception/Barrier Requirements (Female):

- Contraceptive use by women should be consistent with local regulations regarding the

methods of contraception for those participating in clinical studies. A female

participant is eligible to participate if she is not pregnant or breastfeeding, and at

least 1 of the following conditions applies:

- Is NOT a woman of childbearing potential (WOCBP) or Due to lenalidomide being a

thalidomide analogue with risk for embryofetal toxicity and prescribed under a

pregnancy prevention/controlled distribution program, and bortezomib having the

potential to cause fetal harm, WOCBP participants will be eligible if they commit to

either: abstain continuously from heterosexual sexual intercourse as their preferred

and usual lifestyle (abstinent on a long term and persistent basis) and agree to

remain abstinent OR to use birth control as follows: Two methods of reliable birth

control (one method that is highly effective and one additional effective (barrier)

method), beginning 4 weeks prior to initiating treatment with lenalidomide, during

therapy, during dose interruptions and continuing for 4 weeks following

discontinuation of lenalidomide treatment. Thereafter, WOCBP participants must use one

method of reliable birth control that is highly effective for a further 3 months

following discontinuation of belantamab mafodotin, or a further 6 months following

discontinuation of bortezomib, whichever is longer. WOCBP must also agree not to

donate eggs (ova, oocytes) for the purpose of reproduction during treatment, during

dose interruptions and for 28-days following the last dose of lenalidomide, 4 months

following discontinuation of belantamab mafodotin treatment or 7-months following the

last dose of bortezomib, whichever is longer. Two negative pregnancy tests must be

obtained prior to initiating therapy. The first test should be performed within 10-14

days and the second test within 24 hours prior to prescribing the start of

lenalidomide therapy.

The participant should not receive lenalidomide until the investigator has verified that

the results of these pregnancy tests are negative. The investigator should evaluate the

effectiveness of the contraceptive method in relationship to the first dose of study

intervention. The Investigator is responsible for review of medical history, menstrual

history, and recent sexual activity to decrease the risk for inclusion of a woman with an

early undetected pregnancy.

- Sex and Contraception/Barrier Requirements (Male):

- Contraceptive use by men should be consistent with local regulations regarding the

methods of contraception for those participating in clinical studies

- Male participants are eligible to participate if they agree to the following from the

time of first dose of study treatment until 28-days after the last dose of

lenalidomide, 4-months after the last dose of bortezomib, or 6 months after the last

dose of belantamab mafodotin, whichever is longer, to allow for clearance of any

altered sperm: Refrain from donating sperm - Plus either: - Be abstinent from

heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long

term and persistent basis) and agree to remain abstinent OR Must agree to use

contraception/barrier as detailed below: Agree to use a male condom, even if they have

undergone a successful vasectomy, and female partner to use an additional highly

effective contraceptive method with a failure rate of <1% per year when having sexual

intercourse with a WOCBP. Male participants should also use a condom when having

sexual intercourse with pregnant females.

- Capable of giving signed informed consent.

Exclusion Criteria:

- Smoldering multiple myeloma (SMM).

- Prior systemic therapy for multiple myeloma, or SMM. NOTE: An emergency course of

steroids (defined as no greater than 40 mg of dexamethasone, or equivalent per day for

a maximum of 4 days (that is, a total of 160 mg) is permitted. NOTE: Focal palliative

radiation is permitted prior to enrollment, provided that it occurred at least 2 weeks

prior to the first dose of study drug, that the participant has recovered from

radiation-related toxicities, and that the participant did not require corticosteroids

for radiation-induced adverse events.

- Participant is eligible for high dose chemotherapy with ASCT, as determined by a

frailty score of 0 as assessed by the IMWG frailty index.

- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the

national cancer institute (NCI)-common terminology criteria for adverse events (CTCAE)

Version 5.

- Major surgery within 4 weeks prior to the first dose of study drug.

- Presence of active renal condition (infection, requirement for dialysis or any other

significant condition that could affect participant's safety). Participants with

isolated proteinuria resulting from multiple myeloma (MM) are eligible, provided they

fulfil criteria.

- Any serious and/or unstable pre-existing medical, psychiatric disorder or other

conditions (including lab abnormalities) that could interfere with participant's

safety, obtaining informed consent or compliance to the study procedures.

- Evidence of active mucosal or internal bleeding uncontrolled by local therapy and not

explained by reversible coagulopathy.

- Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic

gallstones, or otherwise stable chronic liver disease as per the Investigator's

assessment).

- Participants with previous or concurrent malignancies other than multiple myeloma are

excluded. Exceptions are surgically treated cervical carcinoma in situ, or any other

malignancy that has been considered medically stable for at least 2 years. The

participant must not be receiving active therapy, other than hormonal therapy for this

disease. Note: Participants with curatively treated non-melanoma skin cancer are

allowed without a 2-year restriction.

- Evidence of cardiovascular risk including any of following: Evidence of current

clinically significant untreated arrhythmias, including clinically significant

electrocardiogram (ECG) abnormalities including second degree (Mobitz Type II) or

third degree atrioventricular (AV) block; History of myocardial infarction, acute

coronary syndromes (including unstable angina), coronary angioplasty, or stenting or

bypass grafting within 3 months of Screening.; Class III or IV heart failure as

defined by the New York Heart Association (NYHA) functional classification system;

Uncontrolled hypertension.

- Active infection requiring treatment.

- Known human immunodeficiency virus (HIV) infection.

- Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb),

at Screening or within 3 months prior to first dose of study treatment.

- Positive hepatitis C antibody test result.

- Current corneal epithelial disease except for mild punctate keratopathy. Note:

Participants with mild punctate keratopathy are allowed.

- Intolerance or contraindications to anti-viral prophylaxis.

- Unable to tolerate antithrombotic prophylaxis.

- AL amyloidosis (light chain amyloidosis), active polyneuropathy, organomegaly,

endocrinopathy, monoclonal plasma proliferative disorder, skin changes (POEMS)

syndrome or active plasma cell leukemia at the time of screening.

- Exhibiting clinical signs of or has a known history of meningeal or central nervous

system involvement by multiple myeloma.

- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to

drugs chemically related to belantamab mafodotin, or any of the components of the

study treatment.

- Use of an investigational drug within 14 days or five half-lives (whichever is longer)

preceding the first dose of study drug.

- Plasmapheresis within 7 days prior to the first dose of study drug.

Studien-Rationale

Primary outcome:

1. Number of participants with dose-limiting toxicities (DLTs) (Time Frame - Treatment cycle 1 to 3 (each cycle of 21 days)):
The number of participants with DLTs will be reported.

2. Number of participants with adverse events (AEs) and serious adverse events (SAEs) (Time Frame - Up to an average of 54 months):
AEs and SAEs will be collected.

Secondary outcome:

1. Lenalidomide relative dose intensity (RDI ) of treatment with belantamab mafodotin in combination with VRd (Time Frame - 4 treatment cycles (each cycle of 21 days)):
RDI of treatment with belantamab mafodotin in combination with VRd will be analyzed.

2. Bortezomib RDI of treatment with belantamab mafodotin in combination with VRd (Time Frame - 4 treatment cycles (each cycle of 21 days)):
RDI of treatment with belantamab mafodotin in combination with VRd will be analyzed.

3. Cumulative administered dose of belantamab mafodotin treatment in combination with VRd (Time Frame - 4 treatment cycles (each cycle of 21 days)):
Cumulative administered dose of belantamab mafodotin in treatment in combination with VRd will be analyzed.

4. Maximum plasma concentration (Cmax) of belantamab mafodotin (Time Frame - Up to an average of 52 months):
Blood samples will be collected at indicated time points for pharmacokinetic analysis.

5. Cmax of microtubule inhibitor monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) (Time Frame - Up to an average of 52 months):
Blood samples will be collected at indicated time points for pharmacokinetic analysis.

6. Area under the concentration time curve (AUC) of belantamab mafodotin (Time Frame - Up to an average of 52 months):
Blood samples will be collected at indicated time points for pharmacokinetic analysis.

7. AUC of cys-mcMMAF (Time Frame - Up to an average of 52 months):
Blood samples will be collected at indicated time points for pharmacokinetic analysis.

8. Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin (Time Frame - Up to an average of 52 months):
Serum samples for the analysis of anti-belantamab mafodotin antibodies will be collected. The samples will be tested for anti-belantamab mafodotin antibodies using a tiered-testing scheme consisting of validated screening, confirmation, and titration assays.

9. Titers of ADAs against belantamab mafodotin (Time Frame - Up to an average of 52 months):
Serum samples for the analysis of anti-belantamab mafodotin antibodies will be collected. The samples will be tested for anti-belantamab mafodotin antibodies using a tiered-testing scheme consisting of validated screening, confirmation, and titration assays.

10. Overall Response Rate (ORR) (Time Frame - Up to 52 months):
ORR is defined as the percentage of participants with a confirmed partial response (PR) or better based on the response assessed by the investigator using International Myeloma Working Group (IMWG) criteria.

11. Complete Response Rate (CRR) (Time Frame - Up to 52 months):
CRR is defined as the percentage of participants with a confirmed complete response (CR) or better based on the response assessed by the investigator using IMWG criteria.

12. Rate of Very Good Partial Response (VGPR) or better (Time Frame - Up to 52 months):
Rate of VGPR or better is defined as the percentage of participants with a confirmed VGPR or better based on the response assessed by the investigator using IMWG criteria.

Studien-Arme

  • Experimental: Cohort 1: belantamab mafodotin 1.9 mg/kg Q3/4W + VRd/Rd
    Participants will receive 1.9 milligram /kilogram (mg/kg) Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.
  • Experimental: Cohort 2: belantamab mafodotin 1.4 mg/kg Q6/8W + VRd/Rd
    Participants will receive 1.4 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.
  • Experimental: Cohort 3: belantamab mafodotin 1.9 mg/kg Q6/8W + VRd/Rd
    Participants will receive 1.9 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.
  • Experimental: Cohort 4: belantamab mafodotin 1.0 mg/kg Q3/4W + VRd/Rd
    Participants will receive 1.0 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.
  • Experimental: Cohort 5: belantamab mafodotin 1.4 mg/kg Q3/4W + VRd/Rd
    Participants will receive 1.4 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.
  • Experimental: Cohort 6: belantamab mafodotin 1.4mg/kg cycle 1, 1.0 mg/kg Q9/12W Cycle 4+VRd/Rd
    Based on emerging data from Cohort 2-5, participants will receive 1.4 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1, followed by 1.0 mg/kg dose on Day 1 of every third cycle from cycle 4 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
  • Experimental: Cohort 7: belantamab mafodotin 1.9 mg/kg Cycle 1, 1.4 mg/kg Q9/12W Cycle 4+VRd/Rd
    Based on emerging data from Cohort 2-5, participants will receive 1.9 mg/kg dose of belantamab mafodotin of cycle 1, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 4 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
  • Experimental: Cohort 8a : belantamab mafodotin 1.9 mg/kg Cycle 1,4; 1.4 mg/kg Q9/12W from Cycle 7 +VRd/Rd
    Based on emerging data from Cohort 6-7, participants will receive 1.9 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 4, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 7 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
  • Experimental: Cohort 8b: belantamab mafodotin 1.4 mg/kg Cycle 1,3; 1.0 mg/kg Q9/12W from Cycle 6 +VRd/Rd
    Based on emerging data from Cohort 6-7, participants will receive 1.4 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 3, then 1.0 mg/kg on Day 1 of every third cycle from cycle 6 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.
  • Experimental: Cohort 8c: belantamab mafodotin 1.0 mg/kg Cycle 1,5;1.0 mg/kg Q9/12W from Cycle 9 +VRd/Rd
    Based on emerging data from Cohort 6-7, participants will receive 1.0 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 5, then 1.0 mg/kg on day 1 of every third cycle from cycle 9 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.

Geprüfte Regime

  • Belantamab mafodotin:
    Selected doses of belantamab mafodotin will be administered as intravenous infusion.
  • Bortezomib:
    Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8.
  • Lenalidomide:
    Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.
  • Dexamethasone:
    Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

Quelle: ClinicalTrials.gov


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"Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma"

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