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Multiple Myeloma RefractoryPhase 4CHUQUL_HO001NCT07094048

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

A Phase 4 study testing Target trough IgG level of 8-10 g/L, Target trough IgG level 4-6 g/L and No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L in people with Multiple Myeloma Refractory and Relapsed Multiple Myeloma, run by CHU de Quebec-Universite Laval at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Target trough IgG level of 8-10 g/L, Target trough IgG level 4-6 g/L and No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesCanada
Study dates
5 Jan 2026to Dec 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Less than 18 years old
  • Pregancy or breastfeeding

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Philippe Nadeau, PhD contact

1-418-525-4444 ext. 67324

philippe.nadeau@chudequebec.ca

Canada2 sites, 2 recruiting

  • Santé Québec Chaudière-Appalaches

    Lévis, Quebec, G6W 8A7

    Frederic Larose, MD, frederic.larose.med@ssss.gouv.qc.ca

    Martn Rochette, martin.rochette@ssss.gouv.qc.ca

    Recruiting

  • Centre Intégré de Cancérologie

    Québec, Quebec

    Philippe Nadeau, PhD, 418-525-4444 ext. 67324, philippe.nadeau@chudequebec.ca

    Julie Côté, MD, FRCPC

    Recruiting

Other trials in Canada

About this study

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.

Read the detailed description

Although the effectiveness of immunoglobulins (Ig) has been demonstrated, it remains to be determined whether immunoglobulin administration is necessary for all patients receiving these therapies or only for those with low serum immunoglobulin G (IgG) levels. Furthermore, the optimal target IgG level to achieve in order to reduce the risk of infections is also unknown in this specific population of multiple myeloma patients. Guidance needs to be provided to the clinicians to better support MM patients undergoing this novel therapy by addressing the hypogammaglobulinemia and therefore limiting and ideally avoiding the high risk of infections.

In this prospective, randomized, unblinded, multicenter study, as per the standard of care approach, every patient with relapsed refractory MM receiving a BCMA-directed TCE with history of recurrent or severe infections and/or total IgG level less than 4 g/L will receive Ig support (intravenous ou subcutaneous). Once on Ig supplementation, the optimal target trough IgG level to achieve is not well established. The goal of this study is therefore to better define, in this patient population , the target trough IgG level to achieve a reduction in the incidence of severe infections.

The primary objective is to demonstrate the 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 (SOC) group).

Being tested
Target trough IgG level of 8-10 g/L, Target trough IgG level 4-6 g/L, No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L
Keywords
Immunoglobulins, Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Target trough IgG level of 8-10 g/LDrug

    Also called Standard of care

    Target trough IgG level of 8-10 g/L

  • Target trough IgG level 4-6 g/LDrug

    Also called Experimental

    Target trough IgG level of 4-6 g/L

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

    Also called Crossover

    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

Study groups in NCT07094048
Study groupRoleWhat they receive
Group A IgG level 8-10 g/LActive comparatorImmunoglobulin support (subcutaneous or intravenous)
Receives: Drug: Target trough IgG level of 8-10 g/L
Group B IgG level 4-6 g/LExperimentalImmunglobulin support (subcutaneous or intravenous)
Receives: Drug: Target trough IgG level 4-6 g/L
Group COtherNo immunoglobulin support. If pre specified conditions are met, crossover to Group A or B.
Receives: Drug: No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: From enrollment to 3 months after time of randomization

Secondary outcomes (2)

  1. Minor/Moderate infections rate

    Rates of minor/moderate infection rates

    Measured: From enrollment to 12 monts after randomization

  2. All infection rate

    All infections rate

    Measured: From enrollment to 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start5 Jan 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07094048
Sponsor's protocol ID
MP-20-2025-7948
Acronym
CHUQUL_HO001
Status last verified
Jul 2026
First submitted
11 Jul 2025
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mohan 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.

    PubMed 38443345

  • Compagno 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.

    PubMed 24682509

  • Gardulf 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.

    PubMed 15480339

  • Ducruet 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.

    PubMed 23040368

  • Martin 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.

    PubMed 23167310

  • Perez 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.

    PubMed 28041678

  • Gardulf A. Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs. 2007;21(2):105-16. doi: 10.2165/00063030-200721020-00005.

    PubMed 17402794

  • 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.

    PubMed 23835249

  • 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.

    PubMed 33453130

  • 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.

    PubMed 35176351

  • 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.

    PubMed 29951056

  • 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.

    PubMed 20675197

  • Lee JL, Mohamed Shah N, Makmor-Bakry M, Islahudin FH, Alias H, Noh LM, Mohd Saffian S. A Systematic Review and Meta-regression Analysis on the Impact of Increasing IgG Trough Level on Infection Rates in Primary Immunodeficiency Patients on Intravenous IgG Therapy. J Clin Immunol. 2020 Jul;40(5):682-698. doi: 10.1007/s10875-020-00788-5. Epub 2020 May 16.

    PubMed 32417999

  • Raje N, Anderson K, Einsele H, Efebera Y, Gay F, Hammond SP, Lesokhin AM, Lonial S, Ludwig H, Moreau P, Patel K, Ramasamy K, Mateos MV. Monitoring, prophylaxis, and treatment of infections in patients with MM receiving bispecific antibody therapy: consensus recommendations from an expert panel. Blood Cancer J. 2023 Aug 1;13(1):116. doi: 10.1038/s41408-023-00879-7.

    PubMed 37528088

  • Frerichs KA, Verkleij CPM, Mateos MV, Martin TG, Rodriguez C, Nooka A, Banerjee A, Chastain K, Perales-Puchalt A, Stephenson T, Uhlar C, Kobos R, van der Holt B, Kruyswijk S, Kuipers MT, Groen K, Vishwamitra D, Skerget S, Cortes-Selva D, Doyle M, Zaaijer HL, Zweegman S, Verona RI, van de Donk NWCJ. Teclistamab impairs humoral immunity in patients with heavily pretreated myeloma: importance of immunoglobulin supplementation. Blood Adv. 2024 Jan 9;8(1):194-206. doi: 10.1182/bloodadvances.2023011658.

    PubMed 38052042

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Target trough IgG level of 8-10 g/L, Target trough IgG level 4-6 g/L and No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L in people with Multiple Myeloma Refractory and Relapsed Multiple Myeloma, run by CHU de Quebec-Universite Laval at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philippe Nadeau, PhD (1-418-525-4444 ext. 67324, philippe.nadeau@chudequebec.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severe infections (time frame: From enrollment to 3 months after time of randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07094048, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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