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JOURNAL ONKOLOGIE – STUDIE

Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 5)

Rekrutierend

NCT-Nummer:
NCT04126200

Studienbeginn:
Oktober 2019

Letztes Update:
20.07.2021

Wirkstoff:
Belantamab mafodotin, GSK3174998, feladilimab, Nirogacestat, Dostarlimab, Isatuximab

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

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 19)

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
30322 Atlanta
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
46202 Indianapolis
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
78229 San Antonio
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
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
3000 Melbourne
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
V5Z1M9 Vancouver
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
M5G 2M9 Toronto
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
59037 Lille 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
94805 Villejuif 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
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
06591 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
44033 Ulsan
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
1081 HV Amsterdam
NetherlandsRekrutierend» 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
3584 CX Utrecht
NetherlandsRekrutierend» 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
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
SE-141 86 Stockholm
SwedenRekrutierend» 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:

B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with

multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC)

containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized,

open-label, platform study designed to evaluate the effects of belantamab mafodotin in

combination with other anti-cancer drugs in participants with relapsed/refractory multiple

myeloma. The Platform design incorporates a single master protocol, where multiple treatment

combinations, as sub-studies, will be evaluated simultaneously.

Ein-/Ausschlusskriterien

Inclusion Criteria:

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

informed consent.

- Participants must have histologically or cytologically confirmed diagnosis of Multiple

Myeloma (MM), as defined by the IMWG.

- Participants having at least 3 prior lines of prior anti-myeloma treatments including

an immunodilating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal

antibody.

- Participants with a history of autologous stem cell transplant are eligible for study

participation when, transplant was >100 days prior to study enrolment and with no

active infection(s).

- Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1,

unless ECOG less than equal to (<=)2 is due solely to skeletal complications and/or

skeletal pain due to MM.

- Participants with measurable disease defined as at least one of the following: Serum

M-protein greater than equal to (>=)0.5 gram per deciliter (>=5 gram per liter) or

Urine M-protein >=200 mg per 24 hours or Serum free light chain (FLC) assay: Involved

FLC level >=10 mg per deciliter (>=100 mg per Liter) and an abnormal serum FLC ratio

(<0.26 or >1.65).

Exclusion Criteria:

- Participants with current corneal epithelial disease except mild punctate keratopathy.

- Participants with evidence of cardiovascular risk

- Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy

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

study treatment. History of severe hypersensitivity to other mAb.

- Participants with active infection requiring antibiotic, antiviral, or antifungal

treatment.

- Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma

therapy within <14 days.

- Participants with prior radiotherapy within 2 weeks of start of study therapy.

- Participants with prior allogeneic transplant are prohibited.

- Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy

with lymphodepletion with chemotherapy within 3 months of screening.

- Participants with any major surgery (other than bone-stabilizing surgery) within the

last 30 days.

- Participants with prior treatment with an investigational agent within 14 days or 5

half-lives of receiving the first dose of study drugs, whichever is shorter.

- Participants with >=grade 3 toxicity considered related to prior check-point

inhibitors and that led to treatment discontinuation.

- Participants who have received transfusion of blood products within 2 weeks before the

first dose of study drug.

- Participants must not receive live attenuated vaccines within 30 days prior to first

dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in

any sub-study arm of the platform trial and for at least 70 days following last study

treatment.

Additional Exclusion Criteria for Sub-study 1 and Sub-study 2:

- Participants with autoimmune disease (current or history) or syndrome that required

systemic treatment within the past 2 years.

- Exclusion for a recent (within the past 6 months) history of symptomatic pericarditis.

Additional Exclusion Criteria for Sub-study 3:

- Participants with uncontrolled small and/or large intestinal disease.

- Participants with uncontrolled skin disease.

- Participants with any condition causing hypophosphatemia, hypokalemia or

hypomagnesemia which is refractory to electrolyte replacement.

- Participants with previous administration of a gamma secretase inhibitor.

- Participants with concomitant administration of a strong or moderate CYP3A4 inhibitor

or inducer.

Additional Exclusion Criteria for Sub-study 4:

- Participant has an active autoimmune disease that has required systemic treatment in

the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or

immunosuppressive drugs).

- Participants who have received prior therapy with an anti-programmed death-1

(anti-PD-1), anti-PD-1-ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2)

agent.

- Participant has a diagnosis of immunodeficiency or is receiving systemic steroid

therapy or any other form of immunosuppressive therapy within 7 days prior to the

first dose of study treatment. Use of inhaled steroids, local injection of steroids,

and steroid eye drops are allowed.

Additional Exclusion Criteria for Sub-study 5:

- Participants with Severe hypersensitivity to Isatuximab-irfc or to any of its

excipients.

- Participants with prior treatment with other anti-CD38 monoclonal antibody within 6

months of the first dose of study drug treatment.

- Participants with known intolerance or hypersensitivity to infused proteins products,

sucrose, histidine, and polysorbate 80.

Studien-Rationale

Primary outcome:

1. DE Phase: Number of participants achieving dose limiting toxicities (DLT) (Time Frame - Up to 36 months):
An event is considered to be a dose DLT if the event occurs within the first 21 days of treatment and meets the dose limiting toxicity criteria.

2. DE Phase: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (Time Frame - Up to 36 months):
AEs and SAEs will be collected.

3. DE Phase: Number of participants with abnormality in vital signs (Time Frame - Up to 36 months):
Vital sign measurements will include systolic and diastolic blood pressure, temperature, respiratory rate and pulse rate.

4. DE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters (Time Frame - Up to 36 months):
Blood and urine samples will be collected to evaluate hematology, clinical chemistry and urinalysis lab parameters.

5. CE Phase: Number of participants achieving Overall Response Rate (ORR) (Time Frame - Up to 36 months):
ORR is defined as the percentage of participants with a Partial response (PR) or better, according to the International Myeloma Working Group (IMWG) Response Criteria.

Secondary outcome:

1. DE Phase: Number of participants achieving ORR (Time Frame - Up to 36 months):
ORR is defined as the percentage of participants with PR or better, according to the IMWG Response Criteria.

2. CE Phase: Number of participants achieving Clinical Benefit Rate (CBR) (Time Frame - Up to 36 months):
CBR is defined as the percentage of participants with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.

3. DE Phase and CE Phase: Number of participants achieving Partial Response (Time Frame - Up to 36 months):
Number of participants with PR according to IMWG criteria will be analyzed.

4. DE Phase and CE Phase: Number of participants achieving Very Good Partial Response (VGPR) (Time Frame - Up to 36 months):
Number of participants with VGPR according to IMWG criteria will be analyzed.

5. DE Phase and CE Phase: Number of participants achieving Complete Response (CR) (Time Frame - Up to 36 months):
Participants with CR according to IMWG criteria will be analyzed.

6. DE Phase and CE Phase: Number of participants achieving stringent Complete Response (sCR) (Time Frame - Up to 36 months):
Participants with sCR according to IMWG criteria will be analyzed.

7. DE Phase and CE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of belantamab mafodotin.

8. DE Phase and CE Phase: GSK3174998 concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of GSK3174998.

9. DE Phase and CE Phase: feladilimab concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of feladilimab.

10. DE Phase and CE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of nirogacestat.

11. DE Phase and CE Phase: Dostarlimab concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of dostarlimab.

12. DE Phase and CE Phase: Isatuximab concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of isatuximab.

13. DE Phase and CE Phase: Concentration of anti-drug antibodies (ADAs) against belantamab mafodotin when administered in combination with anti-cancer treatments (Time Frame - Up to 36 months):
Blood samples for concentrations for ADAs will be collected.

14. DE Phase and CE Phase: Concentration of ADAs against GSK3174998 when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples for concentrations for ADAs will be collected.

15. DE Phase and CE Phase: Concentration of ADAs against feladilimab when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples for concentrations for ADAs will be collected.

16. DE Phase and CE Phase: Concentration of ADAs against dostarlimab when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples for concentrations for ADAs will be collected.

17. DE Phase and CE Phase: Concentration of ADAs against isatuximab when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples for concentrations for ADAs will be collected.

18. DE Phase and CE Phase: Number of participants with adverse events of special interest (AESI) (Time Frame - Up to 36 months):
AESIs will be collected.

19. DE Phase and CE Phase: Number of participants with abnormal ocular findings on ophthalmic examination (Time Frame - Up to 36 months):
Ophthalmic examination will assess abnormal findings.

20. CE Phase: Number of participants achieving Progression-free survival (PFS) (Time Frame - Up to 36 months):
PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.

21. CE Phase: Duration of response (DoR) (Time Frame - Up to 36 months):
DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.

22. CE Phase: Time to response (TTR) (Time Frame - Up to 36 months):
TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).

23. CE Phase: Number of participants achieving Overall survival (OS) (Time Frame - Up to 36 months):
OS is defined as the time from randomization until death due to any cause.

24. CE Phase: Number of participants with AEs and SAEs (Time Frame - Up to 36 months):
AEs and SAEs will be collected.

25. CE Phase: Number of participants with AEs leading to discontinuation (Time Frame - Up to 36 months):
Number of participants with AEs leading to discontinuation will be evaluated.

26. CE Phase: Number of participants with dose reduction or delay (Time Frame - Up to 36 months):
Number of participants with dose reduction or delay will be evaluated.

27. CE Phase: Number of participants with abnormality in vital signs (Time Frame - Up to 36 months):
Vital sign measurements will include systolic and diastolic blood pressure, temperature, respiratory rate and pulse rate.

28. CE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters (Time Frame - Up to 36 months):
Blood and urine samples will be collected to evaluate hematology, clinical chemistry and urinalysis lab parameters.

Studien-Arme

  • Experimental: Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1)
  • Experimental: Belantamab mafodotin+feladilimab dose exploration (Sub-study 2)
  • Experimental: Belantamab mafodotin+nirogacestat dose exploration(Sub-study 3)
  • Experimental: Belantamab mafodotin+dostarlimab dose exploration(Sub-study 4)
  • Experimental: Belantamab mafodotin+isatuximab dose exploration (Sub-study 5)
  • Active Comparator: Belantamab mafodotin monotherapy cohort expansion
  • Experimental: Belantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1)
  • Experimental: Belantamab mafodotin+ feladilimab cohort expansion (Sub-study 2)
  • Experimental: Belantamab mafodotin+ nirogacestat cohort expansion(Sub-study 3)
  • Experimental: Belantamab mafodotin+ dostarlimab cohort expansion(Sub-study 4)
  • Experimental: Belantamab mafodotin+ isatuximab cohort expansion(Sub-study 5)

Geprüfte Regime

  • Belantamab mafodotin:
    Belantamab mafodotin will be administered
  • GSK3174998:
    GSK3174998 will be administered
  • Feladilimab:
    feladilimab will be administered.
  • Nirogacestat:
    Nirogacestat will be administered
  • Dostarlimab:
    Dostarlimab will be administered.
  • Isatuximab:
    Isatuximab will be administered

Quelle: ClinicalTrials.gov


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