A Collaborative Community Effort Using Belantamab Mafodotin in Relapsed/Refractory Myeloma

NCT05874193 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro00109162
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 5

Brief Summary

This is a research study to find out if a drug called belantamab mafodotin in combination with dexamethasone, a steroid, can be safely and effectively given in the community setting. Belantamab mafodotin (BLENREP) was approved in the US in August 2020 under an FDA program called accelerated approval. In November 2022, belantamab mafodotin was removed from the market because a study to further confirm its activity in relapsed/refractory multiple myeloma did not deliver a supporting result. However, this confirmatory study demonstrated that some patients may still benefit from treatment with belantamab mafodotin, and that this benefit can be long lasting. Belantamab mafodotin is often given at large academic medical centers every 3 weeks. This study will assess whether it is possible to administer belantamab in the community setting every 6 weeks. It is unknown if administering belantamab every 6 weeks versus every 3 weeks will result in improved safety and/or reduced efficacy.

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

relapsed/refractory Multiple Myeloma; Belantamab Mafodotin; Blenrep

Outcome Measures

Primary Outcomes (1)

• Assess the feasibility of providing Belantamab mafodotin in a heavily pretreated, rural population of patients with multiple myeloma receiving this study regimen every 6 weeks instead of every 3-week cycles.

  Belantamab mafodotin will be evaluated in participants with RRMM (relapsed/refractory multiple myeloma) in the community as assessed through the rate of 'unacceptable toxicity' and response rate as defined in Table 7 through all cycles

  From registration until stopped early due to excess unacceptable toxicity and/or lack of efficacy. Subjects followed for 2 years from end of treatment

Secondary Outcomes (10)

• Describe the efficacy of Belantamab mafodotin specifically in the elderly frail sub-population defined by the IMWG (International Myeloma Working Group) Geriatric Assessment

  From registration until stopped early due to excess unacceptable toxicity and/or lack of efficacy. Subjects followed for 2 years from end of treatment

• Overall Response Rate (ORR) (Full Analysis Population)

  Up to 48 weeks

• Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population)

  Up to 48 weeks

• Duration of Response (DoR) by Investigator Assessment (Full Analysis Population)

  Up to 48 weeks

• Time to Response by Investigator Assessment (Full Analysis Population)

  Up to 48 weeks

Study Arms (1)

Treatment every 6 weeks

EXPERIMENTAL

Treatment every 6 weeks

Drug: Belantamab mafodotin

Interventions

Belantamab mafodotin DRUG

Belantamab mafodotin 2.5mg/kg in 42-day cycles. Every 6 weeks until PD, unacceptable toxicity or withdrawal of consent, whichever comes first

Treatment every 6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Participant must have histologically or cytologically confirmed diagnosis of MM as defined by IMWG, 2016 criteria, have had at least 4 prior therapies, and is relapsed or refractory to an anti-CD38 antibody, an IMID, and a proteasome inhibitor.
• Refractory myeloma is defined as disease that is nonresponsive while on therapy or progresses within 60 days of last therapy. Nonresponsive disease is defined as either failure to achieve at least minimal response or development of progressive disease (PD) while on any therapy.
• \. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 3. Participant must be ≥ 18 years of age 4. Participant must have adequate organ function, defined as follows: 5. Female participants:
• a. A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies: i. Is not a woman of childbearing potential (WOCBP) OR ii. 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.
• A WOCBP must have a negative highly sensitive serum/urine pregnancy test (as required by the protocol) within 72 hours before the first dose of study intervention. WOCBP will have pregnancy testing within 72 hours on day 1 of each cycle.
• The investigator is responsible for review of medical history, menstrual history, and recent sexual activity.
• b. Nonchildbearing potential is defined as follows: i. Premenarchal ii. Premenopausal female with ONE of the following:
• \. Documented hysterectomy 2. Documented bilateral salpingectomy 3. Documented bilateral oophorectomy 4. Documented post-tubal ligation surgery 5. For individuals with permanent infertility due to an alternate medical cause other than the above, (e.g., mullerian agenesis, androgen insensitivity), investigator discretion should be applied to determining study entry.
• a. Note: Documentation can come from the site personnel's: review of participant's medical records, medical examination, or medical history review iii. Postmenopausal female
• A postmenopausal state is define as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required.
• Females on HRT and whose menopausal status is in doubt will be required to use of the non-estrogen hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.
• \. Male participants:
• Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment 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.

You may not qualify if:

• \. Participant must not have evidence of significant cardiovascular risk including any of the following:
• a. 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.
• b. History of recent myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of initiating therapy on this study.
• c. Class III or IV heart failure as defined by the New York Heart Association functional classification system \[NYHA, 1994\] d. Uncontrolled hypertension 13. Participant must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or dexamethasone, or any components of the study drug.
• \. Participant must not have an active infection requiring treatment 15. Known HIV infection, unless the participant can meet all of the following criteria:
• Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \<400 copies/mL
• CD4+ T-cell (CD4+) counts ≥350 cells/uL
• No history of AIDS-defining opportunistic infections within the last 12 months NOTE: consideration must be given to ART and prophylactic antimicrobials that may have a drug: drug interaction and/or overlapping toxicities with belantamab mafodotin or other combination products as relevant (See section 4.3, Concomitant Therapy) 16. 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. Note: presence of Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.
• \. 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.
• NOTE: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, if a confirmatory negative Hepatitis C RNA test is obtained.
• NOTE: Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
• \. 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, prostate cancer or ductal carcinoma in-situ breast cancer not requiring ongoing therapy may be enrolled without a 2-year restriction.
• \. 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

Sponsors & Collaborators

• Cristiana Costa Chase, DO: lead

Study Sites (5)

Johnston Hematology and Oncology of Clayton

Clayton, North Carolina, 27570, United States

Location

Maria Parham Hospital

Henderson, North Carolina, 27536, United States

Location

Scotland Health Care System

Laurinburg, North Carolina, 28352, United States

Location

UNC Health Southeastern

Lumberton, North Carolina, 28358, United States

Location

Johnston Cancer Center

Smithfield, North Carolina, 27577, United States

Location

Related Publications (14)

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• Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016 Dec;43(6):676-681. doi: 10.1053/j.seminoncol.2016.11.004. Epub 2016 Nov 10.

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• Teras LR, DeSantis CE, Cerhan JR, Morton LM, Jemal A, Flowers CR. 2016 US lymphoid malignancy statistics by World Health Organization subtypes. CA Cancer J Clin. 2016 Nov 12;66(6):443-459. doi: 10.3322/caac.21357. Epub 2016 Sep 12.

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• Mina R, Bringhen S, Wildes TM, Zweegman S, Rosko AE. Approach to the Older Adult With Multiple Myeloma. Am Soc Clin Oncol Educ Book. 2019 Jan;39:500-518. doi: 10.1200/EDBK_239067. Epub 2019 May 17.

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• Larocca A, Palumbo A. How I treat fragile myeloma patients. Blood. 2015 Nov 5;126(19):2179-85. doi: 10.1182/blood-2015-05-612960. Epub 2015 Aug 31.

  PMID: 26324701 BACKGROUND

• Palumbo A, Bringhen S, Mateos MV, Larocca A, Facon T, Kumar SK, Offidani M, McCarthy P, Evangelista A, Lonial S, Zweegman S, Musto P, Terpos E, Belch A, Hajek R, Ludwig H, Stewart AK, Moreau P, Anderson K, Einsele H, Durie BG, Dimopoulos MA, Landgren O, San Miguel JF, Richardson P, Sonneveld P, Rajkumar SV. Geriatric assessment predicts survival and toxicities in elderly myeloma patients: an International Myeloma Working Group report. Blood. 2015 Mar 26;125(13):2068-74. doi: 10.1182/blood-2014-12-615187. Epub 2015 Jan 27.

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• Fakhri B, Fiala MA, Tuchman SA, Wildes TM. Undertreatment of Older Patients With Newly Diagnosed Multiple Myeloma in the Era of Novel Therapies. Clin Lymphoma Myeloma Leuk. 2018 Mar;18(3):219-224. doi: 10.1016/j.clml.2018.01.005. Epub 2018 Jan 31.

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• Trudel S, Lendvai N, Popat R, Voorhees PM, Reeves B, Libby EN, Richardson PG, Anderson LD Jr, Sutherland HJ, Yong K, Hoos A, Gorczyca MM, Lahiri S, He Z, Austin DJ, Opalinska JB, Cohen AD. Targeting B-cell maturation antigen with GSK2857916 antibody-drug conjugate in relapsed or refractory multiple myeloma (BMA117159): a dose escalation and expansion phase 1 trial. Lancet Oncol. 2018 Dec;19(12):1641-1653. doi: 10.1016/S1470-2045(18)30576-X. Epub 2018 Nov 12.

  PMID: 30442502 BACKGROUND

• Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Lendvai N, Sborov D, Suvannasankha A, Weisel K, Karlin L, Libby E, Arnulf B, Facon T, Hulin C, Kortum KM, Rodriguez-Otero P, Usmani SZ, Hari P, Baz R, Quach H, Moreau P, Voorhees PM, Gupta I, Hoos A, Zhi E, Baron J, Piontek T, Lewis E, Jewell RC, Dettman EJ, Popat R, Esposti SD, Opalinska J, Richardson P, Cohen AD. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16.

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  BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Cristiana Costa Chase, DO

  Duke Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Fochesato, RN, OCN

CONTACT

984-227-9578; mariagrazia.fochesato@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 24, 2023
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)