Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT01105403
Eligibility Criteria:
Inclusion Criteria:
1. Have multiple myeloma in Stage II or III, according to the criteria of Durie and Salmon.
2. Male or female between 18 and 70 years of age, inclusive. Male and females capable of reproduction must agree to use adequate contraceptive measures (e.g. condom, intrauterine device, oral contraceptive) until 3 months after termination of treatment.
3. Measurable disease, defined by one of the following:
* Serum M protein ≥1.0 g/dL by protein electrophoresis
* Quantifiable immunoglobulin levels and/or
* urinary M protein excretion ≥200 mg/24 hours.
4. All patients have undergone 3 cycles of chemotherapy, with the last dose of chemotherapy given 3 to 8 weeks before study entry.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 2.
6. Life expectancy of \>6 months.
7. Have given their written informed consent to participate in the study
Exclusion Criteria:
1. Have non-secretory myeloma and/or plasma cell leukaemia.
2. History of other malignancies during the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma, or localised prostate carcinoma.
3. Any other clinically significant medical conditions.
4. History of cardiac disease NHYA classification ≥3.
5. Insufficient bone marrow, liver and renal function as assessed by the following clinical laboratory evaluations:
Haemoglobin \<9.0 g/L. Absolute neutrophil count \<1500/µL. Platelet count \<50000/µL. Total bilirubin \>1.5 x upper limit of normal (ULN). Alanine aminotransferase (ALT) and alkaline phosphatase (AP) \>2.5 x ULN. Amylase and lipase \>1.5 x ULN. Serum creatinine \>2.0 x ULN. Prothrombin time (PT) and activated partial thrombo-plastin time (aPTT) \>1.5 x ULN.
6. Pregnant or lactating female patients.
7. Known history of HIV infection or chronic hepatitis B or C infection.
8. Receipt of immunotherapy, radiation therapy, or any investigational drug within 30 days of study drug administration.
9. Prior radiotherapy to more than 3 vertebrae.
10. Active serious bacterial or fungal infections; \>grade 3 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
11. Receipt of haematopoietic cytokines within 10 days of study drug administration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01105403
Study Brief:
Protocol Section:
NCT01105403