A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."

Conditions

• Multiple Myeloma at First Relapse

Eligibility Criteria

Sex

ALL

Age

70 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ixazomib — DRUG
  Ixazomib 3 mg/day (days 1, 8, 15) cycle 1 to until progress
• Iberdomide — DRUG
  Iberdomide 1.6 mg / day (day 1 to 21) cycle 1 to until progress
• Dexamethasone Oral — DRUG
  Cycle 1 and 2 Dexaméthasone 20 mg/day on days 1, 8, 15, 22 Cycle 3 to 6 Dexamethasone 10 mg/day on days 1, 8, 15, 22

Study Details

This is a phase II, multicenter, open-label study to evaluate the rate of patients achieving very good partial response (VGPR) or better to the oral combination Iberdomide Ixazomib Dexamethasone in elderly patients with multiple myeloma at first relapse . The patient population will consist of adult men and women more than 70 years, who meet eligibility criteria. Following the screening period, patients will be enrolled and treated then, they will receive therapy with Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression.

Key Dates

Start date

Dec 14, 2021

Status verified

Apr 2025

Primary completion

Jan 1, 2030

Completion

Jan 1, 2030

Study Design

Enrollment

75 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: assessment of treatment Ixazomib, dexamethasone, iberdomide
  Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression

Primary Outcome Measure

Percentage of patients have very good partial response (VGPR) or better [ Time Frame: approximate 18 months ]