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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT02322320
Eligibility Criteria:
Inclusion Criteria:
Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:
1. Enrolled and randomized on the BMT CTN 0702 protocol.
2. Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4 years post-randomization.
3. Patients without evidence of disease progression at the completion of BMT CTN 0702 protocol specified follow up.
4. Signed Informed Consent Form.
5. Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.
Inclusion Criteria for Optional Long-term Lenalidomide Maintenance Therapy:
Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data AND receive long-term lenalidomide maintenance therapy as part of this study:
1. Enrolled and randomized to BMT CTN 0702.
2. Completion of 3 years of maintenance therapy on BMT CTN 0702.
3. Registered in the mandatory Revlimid REMS® program (formerly the RevAssist® for Study Participants (RASP) program), and be willing and able to comply with the requirements of the Revlimid REMS® program, including counseling, pregnancy testing, and phone surveys.
4. Signed informed consent form.
5. Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.
Exclusion Criteria:
Patients who meet any of the following criteria will be ineligible to receive long-term lenalidomide maintenance therapy as part of this study:
1. Patients who have evidence of disease progression prior to enrollment.
2. Patients who were discontinued from BMT CTN 0702 lenalidomide maintenance therapy, for any reason, prior to the completion of the 3 years of 0702 maintenance.
3. Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) or breastfeeding.
4. Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
5. Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide.
6. Patients unwilling to take Deep Vein Thrombosis (DVT) prophylaxis.
7. Patients who developed a second primary malignancy, excluding non-melanoma skin cancers after initiation of lenalidomide maintenance therapy on BMT CTN 0702.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02322320
Study Brief:
Protocol Section:
NCT02322320