Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 70
Updated:1/11/2019
Start Date:March 2015
End Date:June 30, 2019

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Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN #07LT)

This study is designed to compare long-term outcomes among patients randomized on the BMT CTN
0702 protocol (NCT01109004), "A Trial of Single Autologous Transplant with or without
Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for
Patients with Multiple Myeloma". It is hypothesized that use of novel anti-myeloma agents
will improve long-term progression-free survival (PFS) after high-dose melphalan followed by
autologous hematopoietic cell transplantation (HCT) as compared to a second autologous
transplantation.

This study is designed to compare long-term outcomes among patients randomized on the BMT CTN
0702 protocol (NCT01109004). All patients who consent will be followed for death,
progression, Second Primary Malignancies (SPMs), and Quality of Life (QOL). Patients who do
not consent to the long-term follow-up mechanism or who have experienced progression on the
BMT CTN 0702 study will be followed through the standard Center for International Blood and
Marrow Transplant Research (CIBMTR) long-term follow-up mechanism. Additionally, patients who
are eligible and are willing to continue with lenalidomide as maintenance therapy will be
provided lenalidomide free of charge. These patients will continue to receive lenalidomide as
maintenance therapy until disease progression or discontinuation due to toxicity, death, or
withdrawal from the study. The endpoints assessed will include progression-free survival
(PFS), overall survival (OS), event-free survival (EFS), incidence of second primary
malignancies (SPM) and health quality of life (QOL).

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.
We found this trial at
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1211 Medical Center Dr
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1 Gustave L Levy Pl # 271
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3181 Southwest Sam Jackson Park Road
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101 Manning Dr
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