Phase Ib/II Trial Of Iberdomide-Combinations In Patients With Positive Minimal Residual Disease (>10-5) After Autologous Hematopoietic Cell Transplantation In The Upfront Management Of Patients With Multiple Myeloma (COMMANDER)

NCT05434689 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING

Similar to the paradigm established in other hematologic malignancies that are considered curable, the achievement of MRD(-) status is necessary for long term disease control in MM. The fact that the majority of patients remain MRD (+) after induction therapy and AHCT points to the opportunity to deploy novel agents with complementary mechanism of action and favorable toxicity profile to reach and maintain MRD (-) status. Given its favorable toxicity profile, the convenience of oral administration, and compelling single agent activity even in heavily pretreated MM, iberdomide is likely amenable to long term therapy in patients with high-risk of relapse/progression identified by the persistence of MRD(+). The investigators intend to develop combination(s) of iberdomide with other agents with complementary mechanism of action in the consolidation setting post AHCT in order to achieve and sustain MRD (-).

Details

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	80
Start date	2023-01-18
Completion	2026-10

Conditions

• Multiple Myeloma

Interventions

• Iberdomide
• Daratumumab
• Dexamethasone
• Carfilzomib

Primary outcomes

• Dose limiting toxicity — One year
  Proportion of patients in each regimen who develop dose limiting toxicity
• MRD conversion ( to < 10-5 MM-associated molecules) — Four years
  Rate MRD conversion ( to \<10-5 MM-associated molecules) at completion of consolidation therapy. Patients who are not assessed for MRD at the completion of consolidation (due to any reason, including death, withdrawal from study, loss to follow-up, missed assessment, etc) will be considered as not having achieved MRD conversion.

Countries

United States