Maintenance therapy refers to treatment given to patients after high-dose chemotherapy with autologous stem cell transplant, while continuous therapy refers to treatment given to patients who do not go on to transplant after frontline therapy.
While maintenance/continuous therapy with Revlimid® is the standard of care for treatment of multiple myeloma, there is currently no set time period for the optimal duration of maintenance.
Clinical Trial Results with Revlimid Maintenance Therapy
Large, randomized clinical trials have amply demonstrated the overall survival (OS) benefit of both maintenance and continuous treatment with Revlimid for patients with standard-risk myeloma.
- A meta-analysis of 3 large post-transplant Revlimid maintenance therapy trials (Cancer and Leukemia Group B 100104, Gruppo Italiano Malattie Ematologiche dell'Adulto RV-MM-PI-209, and Intergroupe Francophone du Myélome 2005-02) was published in October, 2017, in Journal of Clinical Oncology.
- The median progression-free survival (PFS) was 52.8 months for the lenalidomide group and 23.5 months for the placebo or observation group (hazard ratio, 0.48; 95% CI, 0.41 to 0.55).
- At a median follow-up time of 79.5 months for all surviving patients, the median OS had not been reached for the Revlimid maintenance group, whereas it was 86.0 months for the placebo or observation group
Continuous Revlimid in non-transplant-eligible patients
- Final, 5-year follow-up data from the French myeloma group’s FIRST trial published in Blood journal in November, 2017, demonstrates that "Revlimid and dexamethasone (Rd) continuous significantly improved survival outcomes versus melphalan, predinsone, and thalidomide (MPT), supporting Rd continuous as a standard of care for patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM)."
- At a median follow-up of 67 months, progression-free survival (PFS) was significantly longer with Rd continuous than with MPT, and median overall survival (OS) was 10 months longer with Rd continuous versus MPT (59.1 vs 49.1 months), and similar with Rd18 (62.3 months).
- In patients achieving complete or very good partial responses, Rd continuous had an approximately 30-month-longer median time to next treatment versus Rd18 (69.5 vs 39.9 months).
While maintenance or continuous therapy with Revlimid is the current standard of care for patients with standard-risk myeloma, sub-group analyses of high-risk patients in clinical trials has established that Revlimid maintenance does not prolong overall survival for many patients with high-risk cytogenetic abnormalities.
Data gleaned from clinical trials has shown that Velcade, a proteasome inhibitor, is an effective therapy for patients with the t(4;14) cytogenetic abnormality. It also showe that it may be more effective for other high-risk abnormalities than Revlimid. No clinical trial has been designed to specifically answer the question, "Is maintenance therapy with Velcade beneficial for newly diagnosed patients with high-risk cytogenetic abnormalities?"
Nevertheless, doctors at Mayo Clinic have designed an "Off-Study" treatment algorithm for both transplant-eligible and transplant ineligible patients, suggesting the following treatments and maintenance/continuous therapies for patients with newly diagnosed multiple myeloma:
Mayo Clinic Off-Study Treatment Alogrithm for Transplant-Eligible Myeloma Patients
Mayo Clinic Off-Study Treatment Alogrithm for Transplant-Ineligible Myeloma Patients