Multiple Myeloma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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).
Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV DNA undetectable during screening.
Participants who are currently receiving physiological doses oral steroids (<10 mg/day), inhaled steroids or ophthalmalogical steroids.

Inclusion Criteria Specific to Sub-study 6 and 7:

Participants with contraception requirements specific to Sub-study 6 and 7 respectively.
Participants with platelets value for Adequate Organ System Function is ≥75 × 10^9/L.

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.
Participants with presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM.

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, 6 & 7:

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 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.

Additional Exclusion Criteria for Sub-study 6 and 7:

Participants with active or history of venous thromboembolism within the past 3 months.
Participants with evidence of active mucosal or internal bleeding
Participants with contraindications to or are unwilling to undergo protocol-required anti-thrombotic prophylaxis or unable to tolerate antithrombolitic prophalaxis,

Additional Exclusion Criteria for Sub-study 6:

Participants who discontinued prior treatment with lenalidomide due to intolerable adverse events

Additional Exclusion Criteria for Sub-study 7:

Participants who discontinued prior treatment with pomalidomide due to intolerable adverse events

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

464

Study ID:

NCT04126200

Recruitment Status:

Recruiting

Sponsor:

GlaxoSmithKline

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 44 Locations for this study

See Locations Near You

GSK Investigational Site
Atlanta Georgia, 30322, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Ajay Nooka
Principal Investigator
GSK Investigational Site
Indianapolis Indiana, 46202, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Attaya Suvannasankha
Principal Investigator
GSK Investigational Site
Boston Massachusetts, 02215, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Paul Richardson
Principal Investigator
GSK Investigational Site
Grand Rapids Michigan, 49546, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Nehal Lakhani
Principal Investigator
GSK Investigational Site
San Antonio Texas, 78229, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Matthew Butler
Principal Investigator
GSK Investigational Site
Madison Wisconsin, 53792, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Natalie Callander
Principal Investigator
GSK Investigational Site
Fitzroy Victoria, 3065, Australia More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
GSKClinicalSupp[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Hang Quach
Principal Investigator
GSK Investigational Site
Melbourne Victoria, 3000, Australia
GSK Investigational Site
São Paulo , 04537, Brazil More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Vania Hungria
Principal Investigator
GSK Investigational Site
Vancouver British Columbia, V5Z1M, Canada More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Kevin Song
Principal Investigator
GSK Investigational Site
Halifax Nova Scotia, B3H 1, Canada More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Darrell White
Principal Investigator
GSK Investigational Site
Toronto Ontario, M5G 2, Canada More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Suzanne Trudel
Principal Investigator
GSK Investigational Site
Lille Cedex , 59037, France More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Thierry Facon
Principal Investigator
GSK Investigational Site
Mont-de-Marsan , 40000, France More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Reza Tabrizi
Principal Investigator
GSK Investigational Site
Villejuif Cedex , 94805, France More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Vincent Ribrag
Principal Investigator
GSK Investigational Site
Frankfurt am Main Hessen, 60590, Germany More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Ivana von Metzler
Principal Investigator
GSK Investigational Site
Leipzig Sachsen, 04103, Germany More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Song-Yau Wang
Principal Investigator
GSK Investigational Site
Kiel Schleswig-Holstein, 24105, Germany More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Natalie Schub
Principal Investigator
GSK Investigational Site
Hamburg , 20246, Germany More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Katja Weisel
Principal Investigator
GSK Investigational Site
Athens , 11528, Greece More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Meletios Athanasios Dimopoulos
Principal Investigator
GSK Investigational Site
Incheon , 21565, Korea, Republic of More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
GSKClinicalSupportH[email protected]
Jae Hoon Lee
Principal Investigator
GSK Investigational Site
Seoul , 03080, Korea, Republic of More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
JaMin Byun
Principal Investigator
GSK Investigational Site
Seoul , 06351, Korea, Republic of More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Kihyun Kim
Principal Investigator
GSK Investigational Site
Seoul , 06591, Korea, Republic of More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Chang Ki Min
Principal Investigator
GSK Investigational Site
Ulsan , 44033, Korea, Republic of More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Jae-Cheol Jo
Principal Investigator
GSK Investigational Site
Mexico City , 01330, Mexico More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Jorge Carlos Torres-Flores
Principal Investigator
GSK Investigational Site
Dordrecht , 3318 , Netherlands More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Mark-David Levin
Principal Investigator
GSK Investigational Site
Leeuwarden , 8934 , Netherlands More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Esther G.M. de Waal
Principal Investigator
GSK Investigational Site
Utrecht , 3584 , Netherlands More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Monique C. Minnema
Principal Investigator
GSK Investigational Site
Oslo , 0450, Norway More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Fredrik Schjesvold
Principal Investigator
GSK Investigational Site
Gdansk , 80-21, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Agata Tyczynska
Principal Investigator
GSK Investigational Site
Katowice , 40-51, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Sebastian Grosicki
Principal Investigator
GSK Investigational Site
Lodz , 93-51, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Pawel Robak
Principal Investigator
GSK Investigational Site
Lublin , 20-08, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Marek Hus
Principal Investigator
GSK Investigational Site
Moscow , 12528, Russian Federation More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Vera A. Zherebtsova
Principal Investigator
GSK Investigational Site
St'Petersburg , 19102, Russian Federation More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Sergey Voloshin
Principal Investigator
GSK Investigational Site
Badalona , 08916, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Albert Oriol Rocafiguera
Principal Investigator
GSK Investigational Site
Madrid , 28027, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Paula Rodriguez Otero
Principal Investigator
GSK Investigational Site
Madrid , 28040, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Daniel Morillo Giles
Principal Investigator
GSK Investigational Site
Madrid , 28041, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Joaquín Martínez López
Principal Investigator
GSK Investigational Site
Pamplona , 31008, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Paula Rodriguez Otero
Principal Investigator
GSK Investigational Site
Pozuelo (Madrid) , 28223, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Aránzazu Alonso Alonso
Principal Investigator
GSK Investigational Site
Falun , SE-79, Sweden More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Max Flogegård
Principal Investigator
GSK Investigational Site
Stockholm , SE-14, Sweden More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Katarina Uttervall
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

464

Study ID:

NCT04126200

Recruitment Status:

Recruiting

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.