NCT01109004: Phase 3 - Stem Cell Transplant With Lenalidomide Maint. NDMM BMT CTN 0702 (STaMINA)

STaMINA Trial

BMT CTN 0702

NCT01109004: Phase 3 - Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators:

Blood and Marrow Transplant Clinical Trials Network

National Cancer Institute (NCI)

The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy or single autologous transplant plus maintenance therapy as part of upfront treatment of multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in all arms.

ClinicalTrials.gov Identifier: NCT01109004

Official Title: A Trial of Single Autologous Transplant With or Without Consolidation Therapy Versus Tandem Autologous Transplant With Lenalidomide Maintenance for Patients With Multiple Myeloma (BMT CTN 0702)

https://clinicaltrials.gov/ct2/show/NCT01109004

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Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

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* Bortezomib (Velcade)

* Lenalidomide (Revlimid)

* Dexamethasone (Decadron)

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Long-term follow-up of BMT CTN 0702 (STaMINA) of postautologous hematopoietic cell transplantation (autoHCT) strategies in the upfront treatment of multiple myeloma (MM).

2020 ASCO Annual Meeting

https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.8506

Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial

J Clin Oncol; 2019

https://pubmed.ncbi.nlm.nih.gov/30653422/

MASS-FIX versus standard methods to predict for PFS and OS among multiple myeloma patients participating on the STAMINA trial.

Conclusions: Mass-Fix is a powerful means to track monoclonal proteins. The full utility of Mass-Fix was not exploited given the absence of a diagnostic sample and the fact that only serum (and not urine) was tested. Despite these limitations, it performed well at pre-induction and at 1 year. Mass-Fix provides a convenient and non-invasive means of predicting for myeloma outcomes. Clinical trial information: NCT01109004

2021 ASCO Annual Meeting

https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.8009

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NCT02322320: Phase 3 - Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)

NCT02322320: Phase 3 - Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT)

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- Multiple locations

- California: City of Hope Duarte

- California: University of California San Francisco

- Colorado: Sarah Cannon/Colorado Blood Cancer Institute Denver

- Florida: Moffitt Cancer Center Tampa

- Illinois: Rush University Medical Center Chicago

- Illinois: University of Chicago

- Massachusetts: Massachusetts General Hospital Boston

- Missouri: Washington University School of Medicine Saint Louis

- New Jersey: Hackensack University Medical Center

- New York: Memorial Sloan-Kettering Cancer Center New York

- New York: Tisch Cancer Institute Mount Sinai Hospital New York

- New York: Roswell Park Cancer Institute Buffalo

- New York: University of Rochester New York

- North Carolina: Wake Forest Baptist Health Winston-Salem

- Pennsylvania: University of Pennsylvania Philadelphia

- Tennessee: Sarah Cannon Research Institute Nashville

- Texas: The University of Texas MD Anderson Cancer Center Houston

- Texas: UT Southwestern Medical Center Dallas

- Texas: Baylor University Medical Center Dallas

- Washington: Fred Hutchinson Cancer Center Seattle