NCT00378105 · REGISTRY CONDITION SEARCH

Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-02-24

The purpose of this study is to determine the safety and efficacy of the bortezomib, lenalidomide and dexamethasone combination in patients with newly diagnosed multiple myeloma. We are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate of the Drug Combination in This Patient Populations.

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outcome · POSTED

Estimated 18-month Progression Free Survival (PFS) Rate

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outcome · POSTED

Percentage of Patients Who Remained in Response for More Than 18 Months

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outcome · POSTED

Estimated 18-month Overall Survival Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Diagnosed with multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria * Must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma * Negative serum or urine pregnancy test * Age 18 years or older * Karnofsky performance status of greater or equal to 60 Exclusion Criteria: * Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment * Renal insufficiency (serum creatinine \>2.5 mg/dL) * Evidence of mucosal or internal bleeding and/or platelet refractory * ANC (absolute neutrophil count)\< 1000 cells/mm3 * Hemoglobin \< 8.0 g/dL * AST (aspartate aminotransferase) or ALT (alanine aminotransferase) greater than or equal to 2 x ULN (upper limit of normal) * Concomitant therapy medications that include corticosteroids * Myocardial infarction within 6 months prior to enrollment according to NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Clinically relevant active infection or serious co-morbid medical conditions * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer * Pregnant or breast-feeding * Serious medical or psychiatric illness likely to interfere with participation in study * Uncontrolled diabetes mellitus * Hypersensitivity to acyclovir or similar anti-viral drug * POEMS syndrome * Known HIV infection * Known active hepatitis B or C viral infection * Known intolerance to steroid therapy
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: Bortezomib
Drug: Lenalidomide
Drug: dexamethasone
label
lenalidomide, dexamethasone, bortezomib combination
type
EXPERIMENTAL

interventions

arm Group Labels
lenalidomide, dexamethasone, bortezomib combination
description
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)
name
Bortezomib
type
DRUG
arm Group Labels
lenalidomide, dexamethasone, bortezomib combination
description
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).
name
Lenalidomide
type
DRUG
arm Group Labels
lenalidomide, dexamethasone, bortezomib combination
description
Taken orally on days 1,2,4,5,8,9,11 of a 21-day cycle for a minimum of 8 cycles.
name
dexamethasone
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 68
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
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.

secondary Outcomes

description
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
measure
Estimated 18-month Progression Free Survival (PFS) Rate
time Frame
PFS rate at 18 months
description
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.
measure
Percentage of Patients Who Remained in Response for More Than 18 Months
time Frame
Response rate at 18 months
description
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.
measure
Estimated 18-month Overall Survival Rate
time Frame
Survival rate at 18 months

Full study description

brief Summary: The purpose of this study is to determine the safety and efficacy of the bortezomib, lenalidomide and dexamethasone combination in patients with newly diagnosed multiple myeloma. We are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients.
detailed Description: * 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.

Source references

references

citation
Dytfeld D, Rosebeck S, Kandarpa M, Mayampurath A, Mellacheruvu D, Alonge MM, Ngoka L, Jasielec J, Richardson PG, Volchenboum S, Nesvizhskii AI, Sreekumar A, Jakubowiak AJ. Proteomic profiling of naive multiple myeloma patient plasma cells identifies pathways associated with favourable response to bortezomib-based treatment regimens. Br J Haematol. 2015 Jul;170(1):66-79. doi: 10.1111/bjh.13394. Epub 2015 Mar 30.
pmid
25824111
type
DERIVED
citation
Richardson PG, Weller E, Lonial S, Jakubowiak AJ, Jagannath S, Raje NS, Avigan DE, Xie W, Ghobrial IM, Schlossman RL, Mazumder A, Munshi NC, Vesole DH, Joyce R, Kaufman JL, Doss D, Warren DL, Lunde LE, Kaster S, Delaney C, Hideshima T, Mitsiades CS, Knight R, Esseltine DL, Anderson KC. Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma. Blood. 2010 Aug 5;116(5):679-86. doi: 10.1182/blood-2010-02-268862. Epub 2010 Apr 12.
pmid
20385792
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice