This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy. This trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide. This trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of >60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.
SparkCures ID | 479 |
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Trial Phase | Phase 2 |
Enrollment | 156 Patients |
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NCT Identifier |
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The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
Exclusion Criteria:
The presence of any of the following will exclude a subject from study enrollment:
Any of the following laboratory abnormalities:
• Absolute neutrophil count < 1,000/μL
• Platelet count < 75,000/μL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/μL for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells.
• Severe renal impairment (Creatinine Clearance [CrCl] < 30 mL/min) requiring dialysis.
Prior history of malignancies, other than MM, unless the subject has been free of the disease for more than 5 years. Allowed exceptions include the following:
•Basal or squamous cell carcinoma of the skin
•Carcinoma in situ of the cervix or breast
• Incidental histological finding of prostate cancer (TNM [tumor, nodes, metastasis] stage of T1a or T1b)
• Congestive heart failure (NY Heart Association Class III or IV)
Subjects who received any of the following within 14 days of initiation of study treatment:
• Major surgery (kyphoplasty is not considered major surgery)
• Use of any anti-myeloma drug therapy
All subjects will be tested for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (antiHBs), and hepatitis B core antibody (antiHBc). Subjects with the following serological testing are considered not eligible:
Note:
All subjects will be tested for hepatitis C antibody. Subjects are not eligible if known seropositive for hepatitis C virus.
Note:
• Subjects who are hepatitis C antibody positive but show no detectable viral RNA for 6 months prior to initiation of study treatment are eligible.
Please visit the ClinicalTrials.gov page for historical site information.
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