Recruiting

Bispecific Antibody

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT07094048

Conditions

Multiple Myeloma Refractory

Relapsed Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Multiple Myeloma Refractory

Relapsed Multiple Myeloma

Study ID

NCT07094048

Start date

Jan 5, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A IgG level 8-10 g/L

Immunoglobulin support (subcutaneous or intravenous)

experimental: Group B IgG level 4-6 g/L

Immunglobulin support (subcutaneous or intravenous)

other: Group C

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

Interventions

Target trough IgG level of 8-10 g/L

Target trough IgG level of 8-10 g/L

Target trough IgG level 4-6 g/L

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/L

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

Primary outcome measure

  • Severe infections [ Time Frame: From enrollment to 3 months after time of randomization ]

Central Contacts and Locations

Central contacts

Philippe Nadeau, PhD

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

Locations

Santé Québec Chaudière-Appalaches

Recruiting

Lévis, Quebec, Canada, G6W 8A7

Contacts

Frederic Larose, MD

frederic.larose.med@ssss.gouv.qc.ca

Martn Rochette

martin.rochette@ssss.gouv.qc.ca

Centre Intégré de Cancérologie

Recruiting

Québec, Quebec, Canada

Contacts

Philippe Nadeau, PhD

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

Principal Investigator:

Julie Côté, MD, FRCPC

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Immunoglobulins
  • Multiple Myeloma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2026-07-22.