Trial Search Results

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator: National Marrow Donor Program

Stanford Investigator(s):

Intervention(s):

  • Drug: Lenalidomide

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting