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NCT00378209 · REGISTRY CONDITION SEARCH

Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory 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
PHASE2
Status at capture
COMPLETED
Registry last update
2016-11-17

The purpose of this study is to evaluate the effectiveness and side effects of the bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory multiple myeloma. Each of these drugs are approved by the U.S Food and Drug Administration, but have not been approved in the combination for treating patients in this setting.

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

The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months

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outcome · POSTED

Objective Response Rate

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outcome · POSTED

Duration of Response

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outcome · POSTED

Progression Free Survival

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outcome · POSTED

Overall Survival

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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: * Diagnosis of multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria * Relapsed or relapsed and refractory disease after receiving between 1 and 3 prior regimens * Negative serum or urine pregnancy test * Age 18 years or older * Karnofsky performance status of 60 or greater Exclusion Criteria: * Grade 2 or greater peripheral neuropathy within 14 days before enrollment * Renal insufficiency (serum creatinine \> 2.5 mg/dL) * Evidence of mucosal or internal bleeding and/or platelet refractory * ANC \< 1000 cells/mm3 * Hemoglobin \< 8.0 g/dL * AST or ALT greater than or equal to 2 x ULN * Concomitant therapy medications that include corticosteroids * Myocardial infarction within 6 months prior to enrollment or has NYHA 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 (within last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, in situ prostate cancer * Pregnant or breast-feeding * Serious medical or psychiatric illness likely to interfere with participation in this clinical 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 * Subjects with primary refractory disease, defined as progression during initial treatment
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They took the dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did not take any study medication.
    intervention Names
    1. Drug: Bortezomib
    2. Drug: Lenalidomide
    3. Drug: Dexamethasone
    label
    lenalidomide, dexamethasone, bortezomib combination
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. lenalidomide, dexamethasone, bortezomib combination
    description
    Given intravenously on days 1,4,8 and 11 of a 21-day cycle for a minimum of 8 cycles.
    name
    Bortezomib
    type
    DRUG
  2. arm Group Labels
    1. lenalidomide, dexamethasone, bortezomib combination
    description
    Taken orally once a day for 2 weeks (days 1-14) of a 21-day cycle for a minimum of 8 cycles
    name
    Lenalidomide
    type
    DRUG
  3. arm Group Labels
    1. lenalidomide, dexamethasone, bortezomib combination
    description
    Taken orally on days 1,2,4,5,8,9,11,and 12 of a 21-day cycle for a minimum of 8 cycles
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
65
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Progressive disease (PD) required one or more of the following: \>25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) \>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) \>25% increased in plasma cells in a bone marrow aspirate or on trephine 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).
    measure
    The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months
    time Frame
    6 months after therapy
secondary Outcomes
  1. description
    Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Objective response was defined by the achievement of at least Partial Response (PR) or better (CR-complete response, nCR-near complete response, and VGPR-very good partial response).
    measure
    Objective Response Rate
    time Frame
    Assessed every cycle for up to 8 cycles and best response was reported
  2. description
    Duration of response will be measured as the time from initiation of a response to first documentation of disease progression or death, or date last known progression-free and alive for those who have not progressed or died.
    measure
    Duration of Response
    time Frame
    Assessed at a median follow-up of 44 months
  3. description
    Progression-free survival is defined as the time from registration to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died.
    measure
    Progression Free Survival
    time Frame
    aassesed at a median follow-up of 44 months
  4. description
    defined as time from treatment initiation to death, or last known to be alive for those who had not died
    measure
    Overall Survival
    time Frame
    assesed at a median follow-up of 44 months
Full study description
brief Summary
The purpose of this study is to evaluate the effectiveness and side effects of the bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory multiple myeloma. Each of these drugs are approved by the U.S Food and Drug Administration, but have not been approved in the combination for treating patients in this setting.
detailed Description
* Participants took the study medication in the clinic on Cycle 1 day 1. Each treatment cycle lasted three weeks. They took the lenalidomide (capsules) every day for the first two weeks only (days 1-14). They took dexamethasone (tablets) on Day 1, 2, 4, 5, 8, 9, 11 and 12 and came to the outpatient treatment center for intravenous bortezomib on Day 1, 4, 8 and 11. The third week of the cycle was a rest period and the participant did not take any study medication. * Certain tests and procedures were performed throughout each treatment cycle at definitive time periods. These tests included: medical history update, physical/neurological examination, skeletal survey (x-rays or scan), blood samples, urine samples, optional bone marrow aspiration/tissue biopsy, 12-lead ECG, and MRI/CT (if needed). * It was expected that participants were going to complete at least 8 cycles of the study, which adds up to 168 days. If the participant completed the first 8 cycles, had stable or responding disease and had not experienced bad side effects, they were allowed to continue treatment on a maintenance schedule, detailed in the protocol, at the study doctor's discretion.
Source references
references
  1. citation
    Richardson PG, Xie W, Jagannath S, Jakubowiak A, Lonial S, Raje NS, Alsina M, Ghobrial IM, Schlossman RL, Munshi NC, Mazumder A, Vesole DH, Kaufman JL, Colson K, McKenney M, Lunde LE, Feather J, Maglio ME, Warren D, Francis D, Hideshima T, Knight R, Esseltine DL, Mitsiades CS, Weller E, Anderson KC. A phase 2 trial of lenalidomide, bortezomib, and dexamethasone in patients with relapsed and relapsed/refractory myeloma. Blood. 2014 Mar 6;123(10):1461-9. doi: 10.1182/blood-2013-07-517276. Epub 2014 Jan 15.
    pmid
    24429336
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
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      offset unit
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice