NCT06107738

Iberdomide and Daratumumab As Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma

IBEX: Phase 2 Trial of Iberdomide + SQ Daratumumab As Post-Autologous Stem Cell Transplant Maintenance Therapy in Multiple Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this phase 2 clinical trial is to learn if patients with Multiple Myeloma who are minimal residual disease positive after initial therapy (including an autologous stem cell transplant \[ASCT\]) will benefit from maintenance therapy with Iberdomide and subcutaneous (SC) Daratumumab. The main questions it aims to answer are: * Assess if giving Iberdomide and the SC Daratumumab in the maintenance setting is an effective treatment and warrants further investigation in patients with residual disease * Is giving Iberdomide and SC Daratumumab maintenance post ASCT a safe option Participants will: * provide informed consent and complete screening assessments for eligibility within 28 days of starting treatment * Screening assessments include specific laboratory tests, a medical history assessment and a physical examination (including temperature, pulse, blood pressure, respirations, height and weight), an assessment of your heart function, a breathing test, cancer imaging, a bone marrow biopsy, minimal residual disease testing (MRD) and a questionnaire * If eligible, patients will start treatment with Iberdomide (1.0 mg on day 1-21 of each 28 day cycle, with an increase to 1.3 mg on Cycle 4 if the 1.0 mg dose was tolerated, to a maximum of 26 cycles or progressive disease, whichever is first) and SC Daratumumab (1800 mg SC on days 1, 8, 15 and 22 of cycle 1 and 2, then 1800 mg SC on Day 1 and 15 of cycle 3-6 and 1800 mg SC on Day 1 for cycles 7-26 to a maximum of 26 cycles or progressive disease, whichever is first) * while receiving treatment on study, physical exams (including temperature, pulse, blood pressure, respirations, height and weight), toxicity assessments, laboratory assessments and questionnaires will be done at various times over the course of the 26 cycles * an MRD assessment is required at 6, 12 and 24 months after starting treatment * End of treatment will occur once 26 cycles are completed, or cancer has progressed whichever comes first. At that time, specific laboratory tests, a physical examination (including temperature, pulse, blood pressure, respirations, height and weight), cancer imaging, a bone marrow biopsy and minimal residual disease testing (MRD) will occur.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Iberdomide	Iberdomide 1.0mg daily for days 1-21 of a 28-day cycle, an increase to 1.3 mg daily on Day 1-21 of a 28-day cycle is allowed at cycle 4 or higher if the 1.0 mg dose was well tolerated.
DRUG	Daratumumab/rHuPH20 Co-formulation	Daratumumab/rHuPH20 will be dosed as follows: * Daratumumab/rHuPH20 1800 mg SC days 1, 8, 15, 22 (28-day cycle; cycles 1-2) * Daratumumab/rHuPH20 1800 mg SC days 1, 15 (28-day cycle; cycles 3-6) * Daratumumab/rHuPH20 1800 mg SC day 1 (28-day cycle; cycles 7-26)

Timeline

• Start date: 2023-12-21
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2023-10-30
• Last updated: 2025-01-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study