Immunoglobulins in Multiple Myeloma Patients Receiving a BCMA-Directed T Cell Engager

NCT07094048 | Recruiting Phase 4 DMC

• 1 other identifier: MP-20-2025-7948
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Bispecific antibody therapies targeting BCMA (B-cell maturation antigen) represent a novel therapeutic approach for patients with multiple myeloma. They are currently used in cases of refractory multiple myeloma but are also being investigated in earlier lines of treatment. However, these new therapies can lead to deeper immunosuppression and exacerbate an underlying immunosuppressive state in patients with multiple myeloma. As a result, infectious complications are common with these therapies and are a significant concern. Therefore, preventing infections in this population is crucial. However, data on the best strategies for prevention are currently lacking.

Conditions

Relapsed Multiple Myeloma; Multiple Myeloma Refractory

Keywords

Immunoglobulins; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Severe infections

  Non-inferiority in the cumulative incidence of severe infections at 3 months between patients on Ig support with a target trough IgG level of 4-6 g/L (experimental group) versus a target trough IgG level of 8-10 g/L (standard of care group)

  From enrollment to 3 months after time of randomization

Secondary Outcomes (2)

• Minor/Moderate infections rate

  From enrollment to 12 monts after randomization

• All infection rate

  From enrollment to 12 months after randomization

Other Outcomes (4)

• Vaccinal response (optional)

  From vaccination (at enrollment) to 1 month after vaccination.

• CM reactivation and infection rate

  From enrollment to 12 months after randomization

• Adverse events related to the administration of the Ig product

  From enrollment to 12 months after randomization

Study Arms (3)

Group A IgG level 8-10 g/L

ACTIVE COMPARATOR

Immunoglobulin support (subcutaneous or intravenous)

Drug: Target trough IgG level of 8-10 g/L

Group B IgG level 4-6 g/L

EXPERIMENTAL

Immunglobulin support (subcutaneous or intravenous)

Drug: Target trough IgG level 4-6 g/L

Group C

OTHER

No immunoglobulin support. If pre specified conditions are met, crossover to Group A or B.

Drug: No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L

Interventions

Target trough IgG level of 8-10 g/L DRUG

Target trough IgG level of 8-10 g/L

Also known as: Standard of care

Group A IgG level 8-10 g/L

Target trough IgG level 4-6 g/L DRUG

Target trough IgG level of 4-6 g/L

Also known as: Experimental

Group B IgG level 4-6 g/L

No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L DRUG

If, during follow-up, the patient presents recurrent or severe infections and/or total IgG level less 4 g/L, crossover to group A or B

Also known as: Crossover

Group C

Eligibility Criteria

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

You may qualify if:

• Multiple myeloma patient:
• ≥ 18 years old
• ≥ 1 prior lines of therapy
• Receiving a BCMA-directed T-cell Engager therapy (starting on treatment)
• On previous Ig support or not

You may not qualify if:

• Less than 18 years old
• Pregancy or breastfeeding

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

Centre Intégré de Cancérologie

Québec, Quebec, Canada

RECRUITING

Related Publications (18)

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• Stiehm ER. Adverse effects of human immunoglobulin therapy. Transfus Med Rev. 2013 Jul;27(3):171-8. doi: 10.1016/j.tmrv.2013.05.004. Epub 2013 Jul 6.

  PMID: 23835249 BACKGROUND

• Jolles S, Michallet M, Agostini C, Albert MH, Edgar D, Ria R, Trentin L, Levy V. Treating secondary antibody deficiency in patients with haematological malignancy: European expert consensus. Eur J Haematol. 2021 Apr;106(4):439-449. doi: 10.1111/ejh.13580. Epub 2021 Feb 2.

  PMID: 33453130 BACKGROUND

• Otani IM, Lehman HK, Jongco AM, Tsao LR, Azar AE, Tarrant TK, Engel E, Walter JE, Truong TQ, Khan DA, Ballow M, Cunningham-Rundles C, Lu H, Kwan M, Barmettler S. Practical guidance for the diagnosis and management of secondary hypogammaglobulinemia: A Work Group Report of the AAAAI Primary Immunodeficiency and Altered Immune Response Committees. J Allergy Clin Immunol. 2022 May;149(5):1525-1560. doi: 10.1016/j.jaci.2022.01.025. Epub 2022 Feb 14.

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• Guo Y, Tian X, Wang X, Xiao Z. Adverse Effects of Immunoglobulin Therapy. Front Immunol. 2018 Jun 8;9:1299. doi: 10.3389/fimmu.2018.01299. eCollection 2018.

  PMID: 29951056 BACKGROUND

• Orange JS, Grossman WJ, Navickis RJ, Wilkes MM. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: A meta-analysis of clinical studies. Clin Immunol. 2010 Oct;137(1):21-30. doi: 10.1016/j.clim.2010.06.012. Epub 2010 Aug 1.

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MeSH Terms

Conditions

Multiple Myeloma

Interventions

Standard of Care; Crossing Over, Genetic

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Homologous Recombination; Recombination, Genetic; Genetic Phenomena

Study Officials

• Dr Julie Côté, MD,FRCPC

  CHU de Québec-Université Laval

  STUDY CHAIR

• Dr Julie Côté, MD,FRCPC

  CHU de Québec-Université Laval

  PRINCIPAL INVESTIGATOR

• Dr Vincent Laroche, MD,FRCPC

  CHU de Québec-Université Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Nadeau, PhD

CONTACT

1-418-525-4444; philippe.nadeau@chudequebec.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Of note, patients in Group C will crossover to Group A or B once meeting the pre specified conditions. Stratified randomization with block design by site.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 30, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CA (1)