Actively Recruiting
Phase 2 Study of Iberdomide and Subcutaneous Daratumumab as Maintenance Therapy After Autologous Stem Cell Transplant in Multiple Myeloma
Led by Barbara Ann Karmanos Cancer Institute · Updated on 2025-01-09
60
Participants Needed
2
Research Sites
158 weeks
Total Duration
On this page
Sponsors
B
Barbara Ann Karmanos Cancer Institute
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating maintenance therapy with Iberdomide and subcutaneous Daratumumab for patients with Multiple Myeloma who remain minimal residual disease positive after initial treatments, including an autologous stem cell transplant (ASCT). This phase 2 trial aims to determine if this combination treatment is effective and safe for patients with residual disease following ASCT. Participants will receive Iberdomide orally at 1.0 mg daily on days 1-21 of each 28-day cycle, with a possible increase to 1.3 mg starting at cycle 4 if tolerated, for up to 26 cycles or until disease progression. Daratumumab is given subcutaneously at 1800 mg on days 1, 8, 15, and 22 during cycles 1 and 2; on days 1 and 15 during cycles 3 to 6; and on day 1 during cycles 7 to 26, also up to 26 cycles or until progression. Participants will complete screening assessments including laboratory tests, medical history, physical exams, heart and breathing tests, imaging, bone marrow biopsy, and MRD testing before starting treatment. During treatment, they will undergo regular physical exams, toxicity and lab assessments, and questionnaires. MRD assessments occur at 6, 12, and 24 months. The study ends after 26 cycles or upon disease progression, followed by final assessments including bone marrow biopsy and imaging. The primary outcome measured is the rate of MRD negativity at 12 months.
CONDITIONS
Official Title
Iberdomide and Daratumumab As Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Multiple Myeloma and received prior Daratumumab-containing induction therapy with at least partial response
- Completed autologous stem cell transplant 90-150 days before registration with no post-transplant therapy or disease progression
- Minimal residual disease positive by ClonoSEQ assay at 10-5 sensitivity or equivalent blood test at enrollment
- Eastern Cooperative Oncology Group Performance Status of 2 or less
- Adequate bone marrow function within 28 days before registration (platelets ≥ 75,000/mm3, hemoglobin ≥ 8 g/dL, ANC ≥ 1,000/mm3)
- Adequate liver function within 28 days before registration (bilirubin ≤ 1.5 times upper limit normal except Gilbert's syndrome, AST and ALT ≤ 3 times upper limit normal)
- Adequate kidney function with creatinine clearance ≥ 30 mL/min within 28 days before registration
- Recovery from autologous stem cell transplant toxicities to Grade 1 or less, except alopecia, fatigue, and amenorrhea
- Females of childbearing potential must have negative pregnancy tests before starting and agree to use two forms of contraception during and after treatment
- Male participants must agree to use condoms during sexual contact with females of childbearing potential and not donate sperm during and after treatment
- Able to provide informed consent
- Aged 18 years or older
You will not qualify if you...
- Active HIV or hepatitis C infections
- Positive hepatitis B surface antigen or detectable hepatitis B virus DNA unless only vaccinated
- Minimal residual disease negative at entry or unable to assess MRD status
- Heart attack or stroke within 90 days before enrollment
- Unable to tolerate required anti-thrombotic or anti-viral prophylaxis
- Major surgery within 28 days before enrollment
- Medical, neurological, or psychiatric conditions preventing safe study participation
- Prior intolerance to Daratumumab requiring discontinuation
- History of other malignancies unless treated and disease-free for at least 2 years, with exceptions
- Signs of meningeal or central nervous system involvement by Multiple Myeloma
- Chronic obstructive pulmonary disease with FEV1 less than 50% predicted
- Moderate or severe persistent asthma in past 2 years or uncontrolled asthma
- Recent myocardial infarction or unstable cardiac conditions
- Known allergies or intolerances to study drug components or related substances
- Pregnant or breastfeeding, or planning pregnancy during study or within 90 days after last dose
- Prolonged QT interval on ECG (>470 msec)
- Use of strong CYP3A4, P-gp, or BCRP inhibitors or inducers before starting therapy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
2
KCI at McLaren Greater Lansing
Lansing, Michigan, United States, 48910
Actively Recruiting
Research Team
J
Jeffrey Zonder
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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