A Study Comparing Iberdomide, Daratumumab And Dexamethasone VersusDaratumumab, Bortezomib, And Dexamethasone In Subjects With Relapsed OrRefractory Multiple Myeloma
- Conditions
- Health Condition 1: C900- Multiple myeloma
- Registration Number
- CTRI/2024/01/062127
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subjects must satisfy the following criteria to be enrolled in the study:
1. Subject is more than or equal to 18 years (there is no upper age limit) of age at the time of signing the informed consent form (ICF)
2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted
3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements
4. Subject has documented diagnosis of MM and measurable disease, defined as any of the following:
a. M-protein quantities more than or equal to 1 g/dL by serum protein electrophoresis (sPEP) or more than or equal to 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP); or
b. Light chain MM without measurable disease in serum or urine: serum-free light chain (FLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio
5. Subject has received one to 2 prior lines of anti-myeloma therapy
6. Subject achieved a response (partial response [PR] or better) to at least 1 prior antimyeloma regimen.
7. Subject must have documented disease progression during or after their last anti-myeloma regimen.
8. Prior treatment with CD38-directed therapy:
In Stage 1, subjects with prior CD38-directed therapy are not eligible.
In Stage 2, prior treatment with CD38-directed therapy is permitted only if all the following are fulfilled:
a. Best response achieved during CD38-directed-containing therapy was > PR.
b. Subject did not progress while receiving CD38-directed therapy or within 60 days of last dose of therapy.
c. Subject did not discontinue CD38-directed therapy due to a related AE.
d. Last dose of daratumumab was more than or equal to 3 months prior to randomization.
9. Prior treatment with bortezomib therapy is permitted, if all the following are fulfilled:
a. Best response achieved during bortezomib-containing therapy was at least a minimal response (MR).
b. Subject did not progress while receiving bortezomib therapy or within 60 days of last dose of therapy.
10. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
11. Females of childbearing potential (FCBP) must:
The presence of any of the following will exclude a subject from enrollment:
1. Subject has any significant medical condition, including active or uncontrolled infection, presence of laboratory abnormality, or psychiatric illness that places the subject at an unacceptable risk for treatment-related complications, if he/she were to participate in the study.
2. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days for mild or asymptomatic infections or within 28 days for severe/critical illness prior to randomization.
3. Subject has any condition that confounds the ability to interpret data from the study.
4. Subject has any of the following laboratory abnormalities:
a. Absolute neutrophil count (ANC) < 1,000 cells/µL. It is not permissible to administer granulocyte colony-stimulating factor (GCSF) to achieve minimum ANC levels.
b. Platelet count: < 75,000 cells/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 50,000 cells/µL for subjects in whom = 50% of bone marrow nucleated cells are plasma cells. It is not permissible to transfuse subjects to achieve minimum platelet counts.
c. Hemoglobin < 8 g/dL ( < 4.9 mmol/L).
d. Estimated glomerular filtration rate (eGFR) < 30 mL/min or requiring dialysis. The eGFR should be calculated using the Modification of Diet in Renal Disease (MDRD) formula adjusted for actual BSA
e. Corrected serum calcium > 13.5 mg/dL ( > 3.4 mmol/L).
f. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN).
g. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert’s syndrome.
5. Subject has plasma cell leukemia, Waldenstrom’s macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
6. Subject has peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain.
7. Subject has gastrointestinal disease that may significantly alter the absorption of iberdomide and/or other oral study treatment.
8. Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for more than or equal to 5 years with the exception of the following noninvasive malignancies:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin in situ (stage 0)
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative
9. Subject with known central nervous system involvement with MM.
10. Subject has received immunosuppressive medication within the last 14 days of initiating study treatment. The following are exceptions to this criterion:
- Intranasal, inhaled, topical or local corticosteroid injections (eg, intra-articular injection)
- Systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone
- Steroids as premedication for hypersensitivity reactions
11. Subject has impaired cardiac function or clinically significant cardiac disease, including:
a. Myocardial infarction within 1 year before randomization, or an unstable or uncontrolled disease/cond
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method