Infectious Complications in Hematological Patients Under Treatment With Bispecific Antibodies.

NCT07609576 | Recruiting DMC

• 1 other identifier: Hemashield study
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, multicenter, observational cohort study involving patients with hematologic malignancies who are receiving bispecific antibody therapy. The primary objective of this study is to evaluate the incidence, type, and severity of infectious complications in hematologic patients undergoing treatment with bispecific antibodies. Secondary objectives include identifying risk factors associated with infection, comparing infectious outcomes across different hematologic malignancies and BsAb types, and assessing the impact of infections on overall treatment outcomes.

Conditions

Lymphoma Neoplasms; Myeloma Multiple; Severe Infection; CMV Reactivation; Biespecific Treatment; Biespecific

Keywords

prophylaxis; infections management

Outcome Measures

Primary Outcomes (1)

• Incidence of infections under biespecific treatment

  to evaluate the incidence, type, and severity of infectious complications in hematologic patients undergoing treatment with bispecific antibodies.

  from enrollment to the end of treatment at 8 weeks

Eligibility Criteria

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

Study Population

Myeloma or lymphoma patients undergoing biespecific treament

You may qualify if:

• Adult patients (≥18 years) diagnosed with hematologic malignancies (e.g., multiple myeloma, non-Hodgkin lymphoma) who are receiving treatment with bispecific antibodies.
• Patients must have initiated BsAb therapy within 30 days prior to study enrollment.
• Ability to provide informed consent.
• Severe infections will be recorded the first year, but infectious events past confirmed relapse or new treatments for the underlying disease will not be recorded.

Sponsors & Collaborators

• Infanta Leonor University Hospital: lead

Study Sites (2)

University Hospital Infanta Leonor

Madrid, Madrid, 28005, Spain

RECRUITING

Infanta Leonor University Hospital

Madrid, Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Infections

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

Central Study Contacts

maria stefania infante, MD, pHD

CONTACT

0034 608008118; mariastefania.infante@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 27, 2026
• Study Start: May 14, 2026
• Primary Completion: June 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)