Clinical trial · Interventional
Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant
Multi-Center,Open-Label,Randomized,Phase 1B Study Evaluating Safety & Tolerability of Intravenous rhMBL in Pts With Multiple Myeloma Receiving Melphalan-Based High-Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Transplant
- 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)
MBL deficient patients enrolled in this protocol are scheduled to be treated with melphalan-based high-dose chemotherapy followed by autologous hematopoietic stem cell transplant (HSCT) for their multiple myeloma. Patients are randomized to 0.5 mg/kg, 1.0 mg/kg, or no rhMBL.
Conditions
Conditions (1)
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 | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- 0 mg/kg
- interventionNames
- Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
- type
- OTHER
- label
- 0.5 mg/kg
- interventionNames
- Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
- type
- OTHER
- label
- 1.0 mg/kg
- interventionNames
- Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Major Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment into the study: * Capable of understanding the protocol requirements and risks and providing written informed consent. * Histologically or cytologically confirmed diagnosis of multiple myeloma. * Mannose-binding lectin level \<300 ng/mL. * Age ≥18 years old. * Score of 0 to 2 on the Zubrod performance status scale. * Patient is scheduled to receive melphalan-based high-dose chemotherapy and autologous HSCT for the treatment of multiple myeloma. Exclusion Criteria: * Concurrent serious medical illness that could potentially interfere with protocol compliance. * Concurrent or previous malignancy associated with a poor prognosis. * Known chronic infectious disease, such as acquired immunodeficiency syndrome (AIDS) or hepatitis (for hepatitis and human immunodeficiency virus \[HIV\] will not be performed). * Positive screening pregnancy test or is breast-feeding. * Female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol. * Known or clinically suspected active brain metastases. * Current participation in another clinical study with an investigational agent and/or use of an investigational drug.
References
Publications (0)
Data not yet available