Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma
The purpose of this study is to see if researchers could get the same good results with less toxicity by using this new approach.
We already know that the three drugs bortezomib, lenalidomide, and dexamethasone given together at the same time are effective. Most physicians therefore treat patients with multiple myeloma with the 3 drug combination. However, the researchers also know that the three drugs given together result in more side effects than when only 2 drugs (bortezomib and dexamethasone or lenalidomide and dexamethasone) are given. The researchers believe that all patients may not necessarily need the three drugs to have good results. In this study, the researchers will first treat your disease with bortezomib and dexamethasone. If the disease is not well controlled with these 2 drugs, only then the third drug, lenalidomide, will be added. By using this sequential approach we may reach the same good results with fewer side effects.
|Multiple Myeloma (MM)||Drug: Bortezomib Drug: Dexamethasone Drug: Lenalidomide||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma|
- overall response rate [ Time Frame: 2 years ](defined as > or = to PR) after 4 cycles of response-adapted sequential therapy, using bortezomib and dexamethasone (BD) followed by the addition of lenalidomide in suboptimal responders
- overall response rate [ Time Frame: 2 years ]for the entire population after up to 8 cycles of response-adapted sequential therapy
- response [ Time Frame: 2 years ]will be tabulated after the completion of cycle four and cycle eight (for those who would have completed 8 cycles), and the overall response rate for the entire population after up to eight cycles will be estimated and compared to the responses reported in the phase II study by Richardson et al. using the 3-drug-combination.
- toxicity [ Time Frame: 2 years ]Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0.
- quality of life (QOL) [ Time Frame: 2 years ]QoL will be assessed in this study using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) and its corresponding multiple myeloma module (EORTC QLQ-MY20).
- progression-free survival (PFS) [ Time Frame: 2 years ]will be estimated for all patients using Kaplan-Meier methodology. This analysis will include all patients regardless of their transplantation status.
- Characterization of genomic mutations of targetable genes [ Time Frame: 2 years ]
- Characterization of immunomodulatory checkpoint pathways in multiple myeloma [ Time Frame: 2 years ]
|Actual Study Start Date:||August 2013|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||August 2018 (Final data collection date for primary outcome measure)|
Experimental: Patients with Multiple Myeloma
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM.
Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m^2, days 1, 8, 15 and 22Drug: Dexamethasone
Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).Drug: Lenalidomide
Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
Please refer to this study by its ClinicalTrials.gov identifier: NCT01919086
|United States, Connecticut|
|Hartford Healthcare Cancer Institute @ Hartford Hospital|
|Hartford, Connecticut, United States, 06102|
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|Memorial Sloan Kettering Monmouth|
|Middletown, New Jersey, United States, 07748|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Memorial Sloan Kettering Westchester|
|West Harrison, New York, United States, 10604|
|Principal Investigator:||Hani Hassoun, MD||Memorial Sloan Kettering Cancer Center|