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:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT01521533
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, aged ≥ 18 years.
2. Diagnosis of relapsed multiple myeloma for which bortezomib/dexamethasone would be given as standard of care.
3. Bortezomib-naïve or bortezomib-sensitive patient (i.e. best response of PR or better, sustained for at least 6 months), who did not receive bortezomib during the last line of therapy for MM prior to this study.
4. Progressive disease according to International Myeloma Working Group criteria.
5. Pre-study WHO Performance Status ≤ 2 and modified CIRS score of less than 7.
6. Signed and dated, written informed consent.
7. Men and women of reproductive potential must agree to follow accepted contraception methods during treatment and for 3 months after completion of treatment.
8. Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN).
9. Acceptable hematology and hemostasis status: Platelet count ≥ 75 x 109/L, ANC \> 0.75x109/L.
10. Acceptable renal function: Serum creatinine ≤1.5 ULN and/or calculated creatinine clearance ≥ 50 mL/min (calculated according to Cockroft \& Gault formula).
11. No clinically significant abnormalities of liver volume, liver hemodynamics or elasticity, measured by abdominal ultrasound.
Exclusion Criteria:
1. The patient has a history of, or is clinically suspicious for, cancer-related Central Nervous System disease.
2. Prior allogeneic stem cell transplant (alloSCT) or patients who are considered to be candidates for alloSCT as assessed by their treating physician.
3. Patient has a history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent.
4. The patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal); diagnosis of fever and neutropenia within 1 week prior to study drug administration.
5. Female patient is pregnant or breast-feeding.
6. Known infection with HIV, active Hepatitis B or Hepatitis C.
7. The patient has a history of prior toxicity from bortezomib or dexamethasone that resulted in permanent discontinuation of respective treatments.
8. Clinical evidence of a current significant (grade 2 or higher) or progressive neuropathy.
9. Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to study drug administration.
10. Uncontrolled hypertension (defined as systolic blood pressure \[BP\] \> 160 mm Hg or diastolic BP \> 100 mm Hg).
11. Myocardial infarction or unstable angina within the past 6 months prior to study drug administration. Heart failure of New York Heart Association functional Class III or IV prior to study drug administration.
12. Evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation).
13. Systemic illnesses or other severe concurrent disease or alcoholism, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and efficacy of the investigational treatments.
14. Known or suspected of not being able to comply with the trial protocol.
15. Having been previously enrolled in this clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01521533
Study Brief:
Protocol Section:
NCT01521533