Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00378105|
Recruitment Status : Active, not recruiting
First Posted : September 19, 2006
Results First Posted : August 19, 2014
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Bortezomib Drug: Lenalidomide Drug: dexamethasone||Phase 1 Phase 2|
- The safe dose of dexamethasone is already known. The dose of bortezomib and lenalidomide will be increased during the study until the best and safest amount (or dose) is identified. The participant's dose of the study drugs will depend on when they enter the study.
- In this study each cycle will be 21 days and participants will begin the study medication in the clinic on Cycle 1 Day 1. Lenalidomide (capsules) will be taken daily for the first 2 weeks only (Day 1-14). Dexamethasone (tablets) will be taken on Day 1, 2, 4, 5, 8, 9, 11 and 12. Bortezomib will be given intravenously in the outpatient treatment clinic on Day 1, 4, 8 and 11. The third week is a rest period and no study medication will be given.
- During the course of the study treatment, tests and procedures will be performed at designated time periods. This includes; medical history updates, physical/neurological examinations, skeletal survey (x-rays or scan), blood samples, optional bone marrow aspiration/tissue biopsy, urine samples, 12-lead ECG, and MRI/CT scan (if needed).
- It is expected that study participants will receive study treatment for 8 cycles (168 days). If the participant completes the first 8 cycles of the study, has stable or responding disease and has not experienced bad side effects, they will be allowed to continue treatment on a maintenance schedule, detailed in the protocol, at the study doctor's discretion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase I/II Study of the Safety and Efficacy of Bortezomib, Lenalidomide and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma|
|Study Start Date :||September 2006|
|Primary Completion Date :||July 2009|
|Estimated Study Completion Date :||February 2019|
Experimental: lenalidomide, dexamethasone, bortezomib combination
In this study each cycle will be 21 days and participants will begin the study medication in the clinic on Cycle 1 Day 1. Lenalidomide (capsules) will be taken daily for the first 2 weeks only (Day 1-14). Dexamethasone (tablets) will be taken on Day 1, 2, 4, 5, 8, 9, 11 and 12. Bortezomib will be given intravenously in the outpatient treatment clinic on Day 1, 4, 8 and 11. The third week is a rest period and no study medication will be given.
Intravenously on days 1, 4, 8 and 11 of a 21 day cycle for a minimum of 8 cycles (dosage will vary depending upon when the participant enters the trial)Drug: Lenalidomide
Taken orally twice a day for 2 weeks (days 1-14) of each 21-day cycle for a minimum of 8 cycles (dosage will vary depending upon when participant enters trial).Drug: dexamethasone
Taken orally on days 1,2,4,5,8,9,11 of a 21-day cycle for a minimum of 8 cycles.
- Objective Response Rate of the Drug Combination in This Patient Populations. [ Time Frame: Full response assessment was conducted at the end of cycle 8 (average of168 days) and after cycle 4 (84 days) for patients proceeding to transplant. ]Overall Response (OR) was defined as partial response (PR) or better. Response was assessed according to European Group for Blood and Marrow Transplant criteria, modified to include nCR and VGPR, from the International Uniform Response Criteria.
- Estimated 18-month Progression Free Survival (PFS) Rate [ Time Frame: PFS rate at 18 months ]
PD from European Bone Marrow Transplant (EBMT) Response Criteria Required one or more:
>25% increased in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, or >25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation), or >25% increased in plasma cells in a bone marrow aspirate or biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas.
Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture).
Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).
PFS was measured from treatment initiation to progression or death, censored at the date patients were last known to be alive and disease free
- Percentage of Patients Who Remained in Response for More Than 18 Months [ Time Frame: Response rate at 18 months ]Duration of response was measured from first response to progression or death, censored at the date patients were last known to be alive and disease free for patients who had not progressed or died.
- Estimated 18-month Overall Survival Rate [ Time Frame: Survival rate at 18 months ]Overall survival was measured from treatment initiation to death, censored at the date patients were last known to be alive for those who had not died.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378105
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Paul Richardson, MD||Dana-Farber Cancer Institute|