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Trial record 55 of 864 for:    LENALIDOMIDE AND Angiogenesis

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

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ClinicalTrials.gov Identifier: NCT02322320
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
National Marrow Donor Program
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE December 17, 2014
First Posted Date  ICMJE December 23, 2014
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date June 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2014)
Compare the PFS as a time to event analysis from randomization on the BMT CTN 0702 protocol between the three randomized treatment arms as a pairwise comparison. [ Time Frame: 5 years post randomization on BMT CTN 0702 ]
The primary analysis will include all randomized subjects from the BMT CTN 0702 protocol, classified according to their randomized treatment allocation, irrespective of treatment actually received [intent-to-treat]. The time to this event is the time from randomization on the BMT CTN 0702 protocol to progression, initiation of non-protocol anti-myeloma therapy, or death from any cause. Patients will be censored at loss to follow-up or end of 2018, whichever comes first. Deaths without progression are treated as failures no matter when they occur. The analysis will be conducted once all living patients have been followed for 5-years post randomization on the BMT CTN 0702 protocol.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02322320 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2014)
  • Overall survival from randomization on the BMT CTN 0702 protocol [ Time Frame: 5 years post randomization on BMT CTN 0702 ]
    Overall survival (OS) time will be calculated as the time from randomization on the BMT CTN 0702 protocol to death, loss to follow-up or the end of the study, whichever comes first. Patients alive at the time of last observation or lost to follow-up will be censored at the date of last contact. OS will be compared between treatment arms.
  • Event-free survival from randomization on the BMT CTN 0702 protocol [ Time Frame: 5 years post randomization on BMT CTN 0702 ]
    Event-free survival (EFS) will be calculated as the time from randomization on the BMT CTN 0702 protocol to death, progression, second primary malignancy, loss to follow-up or the end of the study, whichever comes first. Patients alive at the time of last observation of lost to follow-up will be censored at the date of last contact. EFS will be compared between treatment arms.
  • Unexpected Grades 3 - 5 adverse events [ Time Frame: 5 years post randomization on BMT CTN 0702 ]
    The development of any SPMs excludes non-melanoma skin cancers. Death without SPMs will be considered a competing risk for this event. The cumulative incidence of SPMs will be compared between treatment arms.
  • Health Quality of Life [ Time Frame: 5 years post randomization on BMT CTN 0702 ]
    Health quality of life (HQL) will be compared between all treatment groups utilizing the FACT-BMT and SF-36.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)
Official Title  ICMJE Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN #07LT)
Brief Summary 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.
Detailed Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Drug: Lenalidomide
In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
Other Name: Revlimid™
Study Arms  ICMJE
  • Active Comparator: Tandem Auto Transplant
    Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
    Intervention: Drug: Lenalidomide
  • Active Comparator: RVD Consolidation
    Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
    Intervention: Drug: Lenalidomide
  • Active Comparator: Lenalidomide Maintenance
    Initial autologous transplant followed by lenalidomide maintenance
    Intervention: Drug: Lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2018)
273
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2014)
450
Actual Study Completion Date  ICMJE June 7, 2019
Actual Primary Completion Date June 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02322320
Other Study ID Numbers  ICMJE BMTCTN07LT
U01HL069294-05 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Within 6 months of official study closure at participating sites.
Access Criteria: Available to the public
URL: https://biolincc.nhlbi.nih.gov/home/
Responsible Party National Heart, Lung, and Blood Institute (NHLBI)
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE
  • Blood and Marrow Transplant Clinical Trials Network
  • National Cancer Institute (NCI)
  • National Marrow Donor Program
Investigators  ICMJE
Study Director: Mary Horowitz, MD Center for International Blood and Marrow Transplant Research
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP