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

NCT ID: NCT05874193

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-31

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsed/Refractory Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment every 6 weeks

Treatment every 6 weeks

Group Type EXPERIMENTAL

Belantamab mafodotin

Intervention Type DRUG

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

Interventions

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Belantamab mafodotin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. 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.

1. 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.

2\. 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:

1\. 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

1. 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.
2. 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.

6\. 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:

1. Refrain from donating sperm PLUS, either
2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.

OR c. Must agree to use contraception/barrier as detailed below: i. Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).

7\. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be ≤ Grade 1 at the time of enrollment except for alopecia or at a stable baseline for at least 6 weeks.

8\. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent 9. Participant must agree to not wear contact lenses while on the study 10. Participant must agree to have a detailed eye exam by an eye care specialist prior to each treatment of Belantamab mafodotin and agree to use preservative-free lubricant eye drops at least 4 times every day while on treatment


12\. 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.

14\. Participant must not have an active infection requiring treatment 15. Known HIV infection, unless the participant can meet all of the following criteria:
1. Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \<400 copies/mL
2. CD4+ T-cell (CD4+) counts ≥350 cells/uL
3. 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.

17\. 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.

18\. 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.

19\. 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cristiana Costa Chase, DO

OTHER

Sponsor Role lead

Responsible Party

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Cristiana Costa Chase, DO

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Cristiana Costa Chase, DO

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Johnston Hematology and Oncology of Clayton

Clayton, North Carolina, United States

Site Status

Maria Parham Hospital

Henderson, North Carolina, United States

Site Status

Scotland Health Care System

Laurinburg, North Carolina, United States

Site Status

UNC Health Southeastern

Lumberton, North Carolina, United States

Site Status

Johnston Cancer Center

Smithfield, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Maria Fochesato, RN, OCN

Role: CONTACT

984-227-9578

Facility Contacts

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Maria Fochesato, RN, OCN

Role: primary

984-227-9875

Maria Fochesato, RN, OCN

Role: primary

984-227-9578

Maria Fochesato, RN, OCN

Role: primary

984-227-9578

Maria Fochesato, RN, OCN

Role: primary

984-227-9578

Maria Fochesato, RN, OCN

Role: primary

984-227-9875

References

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Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. doi: 10.1056/NEJMra1011442. No abstract available.

Reference Type BACKGROUND
PMID: 21410373 (View on PubMed)

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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PMID: 27618563 (View on PubMed)

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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Smith CJ, Ambs S, Landgren O. Biological determinants of health disparities in multiple myeloma. Blood Cancer J. 2018 Aug 28;8(9):85. doi: 10.1038/s41408-018-0118-z.

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PMID: 30190459 (View on PubMed)

Duma N, Azam T, Riaz IB, Gonzalez-Velez M, Ailawadhi S, Go R. Representation of Minorities and Elderly Patients in Multiple Myeloma Clinical Trials. Oncologist. 2018 Sep;23(9):1076-1078. doi: 10.1634/theoncologist.2017-0592. Epub 2018 Apr 26.

Reference Type BACKGROUND
PMID: 29700207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26324701 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 30442502 (View on PubMed)

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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Lu YC, Weng WC, Lee H. Functional roles of calreticulin in cancer biology. Biomed Res Int. 2015;2015:526524. doi: 10.1155/2015/526524. Epub 2015 Mar 31.

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Yang H, Wang H, Andersson U. Targeting Inflammation Driven by HMGB1. Front Immunol. 2020 Mar 20;11:484. doi: 10.3389/fimmu.2020.00484. eCollection 2020.

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PMID: 32265930 (View on PubMed)

Chopra B, Dave C, Gorczyca M, et al. GSK2857916 Investigator's Brochure. 2019;6:1-150

Reference Type BACKGROUND

Other Identifiers

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Pro00109162

Identifier Type: -

Identifier Source: org_study_id

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