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

Phase 1

• Conditions: Multiple Myeloma

• Registration Number: JPRN-jRCT2061230056
• Lead Sponsor: Ishibashi Hideyasu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 464

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DE Phase<br>Number of participants achieving dose limiting toxicities (DLT)<br>Number of participants with adverse events (AEs) and serious adverse events (SAEs)<br>Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters<br><br>CE Phase<br>Overall Response Rate (ORR)