Actively Recruiting
Iberdomide and Daratumumab As Maintenance Therapy After an Autologous Stem Cell Transplant for 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
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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