Iberdomide and Daratumumab as Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma
Status:
Recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborators:
Bristol-Myers Squibb Janssen Pharmaceuticals Multiple Myeloma Research Consortium