RECRUITING

Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma

Conditions

Multiple Myeloma Belantamab Mafodotin Elotuzumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to determine if two drugs approved for treating multiple myeloma, belantamab mafodotin and elotuzumab, are safe and more effective when used together.

Official Title

Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma

Quick Facts

Study Start:2022-02-21

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05002816

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participant must have MM that has relapsed after or is refractory to at least 3 prior lines of therapy. Relapsed/refractory disease as defined by IMWG criteria. 2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 3. Participant must be ≥ 18 years of age 4. Prior line of therapy must include iMID, proteasome inhibitor, and anti-CD38 monoclonal antibody. Prior elotuzumab is allowed. 5. Participant must have adequate organ function, defined as: * ANC ≥0.5X 109/L * Hemoglobin ≥8.0 g/dL * Platelets ≥50X 109/L * Total bilirubin ≤1.5X ULN (Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) * ALT ≤2.5 X ULN * eGRF ≥40 mL/min/ 1.73 m2 * Spot urine (albumin/creatinine ratios) \<500 mg/g (56 mg/mmol) OR * Urine dipstick Negative/trace (if ≥1+ only eligible if confirmed \<500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void) 6. Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Is not a woman of childbearing potential (WOCBP) OR * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency (as described in Appendix 3), during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. * ≥45 years of age and has not had menses for \>1 year * Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure. 7. Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 8. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.035.0) must be ≤ Grade 2 at the time of enrolment except for alopecia. 9. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent	1. Participant must not have current corneal epithelial disease except mild changes in corneal epithelium 2. Participant must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria 3. Participant must not have 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 and stable chronic kidney disease are eligible, provided they fulfil inclusion criteria 4. Participant must not use contact lenses while participating in this study 5. Participant must not be simultaneously enrolled in any other interventional clinical trial 6. Participant must not have used an investigational drug or approved systemic anti-myeloma therapy (systemic steroids are allowed) within 14 days preceding the first dose of study drug 7. Participant must not have had plasmapheresis within 7 days prior to first dose of study treatment 8. Participant must not have received prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs 9. Participant must not have had major surgery ≤ 4 weeks prior to initiating study treatment 10. Participant must not have any evidence of active mucosal or internal bleeding 11. Participant must not have evidence of cardiovascular risk including any of the following: * Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block. * History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of Screening. * Class III or IV heart failure as defined by the New York Heart Association functional classification system \[NYHA, 1994\] * Uncontrolled hypertension 12. Participant must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment 13. Participant must not have an active infection requiring IV antimicrobial treatment 14. Participant must not have known HIV infection 15. Participant must not have 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 16. Participant must not have positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment. 17. Participant must not have invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction. 18. Participant must not have 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 19. Participants must not be pregnant or lactating

Inclusion Criteria

Exclusion Criteria

1. Participant must have MM that has relapsed after or is refractory to at least 3 prior lines of therapy. Relapsed/refractory disease as defined by IMWG criteria.
2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
3. Participant must be ≥ 18 years of age
4. Prior line of therapy must include iMID, proteasome inhibitor, and anti-CD38 monoclonal antibody. Prior elotuzumab is allowed.
5. Participant must have adequate organ function, defined as:
* ANC ≥0.5X 109/L
* Hemoglobin ≥8.0 g/dL
* Platelets ≥50X 109/L
* Total bilirubin ≤1.5X ULN (Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
* ALT ≤2.5 X ULN
* eGRF ≥40 mL/min/ 1.73 m2
* Spot urine (albumin/creatinine ratios) \<500 mg/g (56 mg/mmol) OR
* Urine dipstick Negative/trace (if ≥1+ only eligible if confirmed \<500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void)
6. Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Is not a woman of childbearing potential (WOCBP) OR
* Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency (as described in Appendix 3), during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
* ≥45 years of age and has not had menses for \>1 year
* Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
7. Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
8. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.035.0) must be ≤ Grade 2 at the time of enrolment except for alopecia.
9. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent

1. Participant must not have current corneal epithelial disease except mild changes in corneal epithelium
2. Participant must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria
3. Participant must not have 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 and stable chronic kidney disease are eligible, provided they fulfil inclusion criteria
4. Participant must not use contact lenses while participating in this study
5. Participant must not be simultaneously enrolled in any other interventional clinical trial
6. Participant must not have used an investigational drug or approved systemic anti-myeloma therapy (systemic steroids are allowed) within 14 days preceding the first dose of study drug
7. Participant must not have had plasmapheresis within 7 days prior to first dose of study treatment
8. Participant must not have received prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs
9. Participant must not have had major surgery ≤ 4 weeks prior to initiating study treatment
10. Participant must not have any evidence of active mucosal or internal bleeding
11. Participant must not have evidence of cardiovascular risk including any of the following:
* Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.
* History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of Screening.
* Class III or IV heart failure as defined by the New York Heart Association functional classification system \[NYHA, 1994\]
* Uncontrolled hypertension
12. Participant must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment
13. Participant must not have an active infection requiring IV antimicrobial treatment
14. Participant must not have known HIV infection
15. Participant must not have 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
16. Participant must not have positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
17. Participant must not have invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
18. Participant must not have 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
19. Participants must not be pregnant or lactating

Contacts and Locations

Study Contact

Natalia Neparidze, MD

CONTACT

203-430-4881

natalia.neparidze@yale.edu

Kylie Boyhen

CONTACT

203-752-7835

kylie.boyhen@yale.edu

Study Locations (Sites)

Yale New Haven Hospital

New Haven, Connecticut, 06512

United States

Collaborators and Investigators

Sponsor: Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-21

Study Completion Date2026-12

Study Record Updates

Study Start Date2022-02-21

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Belantamab Mafodotin
Elotuzumab

Additional Relevant MeSH Terms

Multiple Myeloma