Clinical trial · Interventional
Immunoglobulins in Multiple Myeloma Patients Receiving a BCMA-Directed T Cell Engager
NCT07094048CI-TRIAL-00118867CHUQUL_HO001recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma Refractory | — | UNRESOLVED | — |
| Relapsed Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L | Drug | — | UNRESOLVED |
| Target trough IgG level 4-6 g/L | Drug | — | UNRESOLVED |
| Target trough IgG level of 8-10 g/L | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Group A IgG level 8-10 g/L
- description
- Immunoglobulin support (subcutaneous or intravenous)
- interventionNames
- Drug: Target trough IgG level of 8-10 g/L
- type
- EXPERIMENTAL
- label
- Group B IgG level 4-6 g/L
- description
- Immunglobulin support (subcutaneous or intravenous)
- interventionNames
- Drug: Target trough IgG level 4-6 g/L
- type
- OTHER
- label
- Group C
- description
- No immunoglobulin support. If pre specified conditions are met, crossover to Group A or B.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Less than 18 years old * Pregancy or breastfeeding
References
Publications (18)
- BACKGROUNDMohan M, Monge J, Shah N, Luan D, Forsberg M, Bhatlapenumarthi V, Balev M, Patwari A, Cheruvalath H, Bhutani D, Thanendrarajan S, Dhakal B, Zangari M, Al-Hadidi S, Cooper D, Lentzsch S, van Rhee F, D'Souza A, Szabo A, Schinke C, Chakraborty R. Teclistamab in relapsed refractory multiple myeloma: multi-institutional real-world study. Blood Cancer J. 2024 Mar 5;14(1):35. doi: 10.1038/s41408-024-01003-z. PMID 38443345
- BACKGROUNDCompagno N, Cinetto F, Semenzato G, Agostini C. Subcutaneous immunoglobulin in lymphoproliferative disorders and rituximab-related secondary hypogammaglobulinemia: a single-center experience in 61 patients. Haematologica. 2014 Jun;99(6):1101-6. doi: 10.3324/haematol.2013.101261. Epub 2014 Mar 28. PMID 24682509
- BACKGROUNDGardulf A, Nicolay U, Math D, Asensio O, Bernatowska E, Bock A, Costa-Carvalho BT, Granert C, Haag S, Hernandez D, Kiessling P, Kus J, Matamoros N, Niehues T, Schmidt S, Schulze I, Borte M. Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG self-infusions at home. J Allergy Clin Immunol. 2004 Oct;114(4):936-42. doi: 10.1016/j.jaci.2004.06.053. PMID 15480339
- BACKGROUNDDucruet T, Levasseur MC, Des Roches A, Kafal A, Dicaire R, Haddad E. Pharmacoeconomic advantages of subcutaneous versus intravenous immunoglobulin treatment in a Canadian pediatric center. J Allergy Clin Immunol. 2013 Feb;131(2):585-7.e1-3. doi: 10.1016/j.jaci.2012.08.022. Epub 2012 Oct 2. No abstract available. PMID 23040368
- BACKGROUNDMartin A, Lavoie L, Goetghebeur M, Schellenberg R. Economic benefits of subcutaneous rapid push versus intravenous immunoglobulin infusion therapy in adult patients with primary immune deficiency. Transfus Med. 2013 Feb;23(1):55-60. doi: 10.1111/j.1365-3148.2012.01201.x. Epub 2012 Nov 20. PMID 23167310
- BACKGROUNDPerez EE, Orange JS, Bonilla F, Chinen J, Chinn IK, Dorsey M, El-Gamal Y, Harville TO, Hossny E, Mazer B, Nelson R, Secord E, Jordan SC, Stiehm ER, Vo AA, Ballow M. Update on the use of immunoglobulin in human disease: A review of evidence. J Allergy Clin Immunol. 2017 Mar;139(3S):S1-S46. doi: 10.1016/j.jaci.2016.09.023. Epub 2016 Dec 29.