Multiple MyelomaPhase 2NCT00366106
Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma
A Phase 2 study testing bortezomib, dexamethasone and doxorubicin HCl liposome in people with Multiple Myeloma, run by Accelerated Community Oncology Research Network at 15 sites in United States.
Trial summary
The current study is being conducted to evaluate the possibility that a different schedule of bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib dosing for a longer period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- bortezomib, dexamethasone and doxorubicin HCl liposome
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 32 participants
- Where
- 15 sitesUnited States
- Study dates
- Jul 2006to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 18 years of age.
- Patient has confirmed diagnosis of relapsed/refractory multiple myeloma with measurable disease by serum or urine. Measurable disease defined as monoclonal protein of ≥ 1g/dl on serum protein electrophoresis (SPEP) or > 200 mg urine M protein/ 24 hours
- Patient has received at least 1 prior treatment regimen. (Prior treatment with bortezomib is allowed.)
- Patient has ECOG ≤ 2
- Patient provides voluntary written informed consent before performance of any study-relates procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Patients who have received prior high dose chemotherapy with stem cell support are eligible for this study.
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
Who cannot join
- Patient has a platelet count of < 50, 000 cells/mm³, within 14 days before enrollment.
- Patient has an absolute neutrophil count (ANC) ≤ 750/mm³ within 14 days before enrollment.
- Patient has a calculated or measured creatinine clearance of < 20 mL/min within 14 days before enrollment and/or serum creatinine ≥ 2.5 mg/dl.
- Patient has hemoglobin < 7.5 g/dl.
- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
- 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. Prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant.
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- Patient has received a total cumulative dosage of anthracyclines exceeding 550 mg/m2.
- Patient has hypersensitivity to boron or mannitol.
- Patient has history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of DOXIL.
- Patient has clinically significant coexisting illness unrelated to myeloma.
- Patient has uncontrolled diabetes.
- Patient has plasma cell leukemia.
- Patient has serum bilirubin > 1.5 x upper normal limit, alanine aminotransaminase (ALT), aspartate aminotransferase (AST) > 2.5 x upper normal limit (ULN), or alkaline phosphatase > 2.5 x ULN.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG)pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs within 14 days before enrollment.
- Patient has serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Northeast Georgia Cancer Care
Athens, Georgia, 30607
Augusta Oncology Associates, PC
Augusta, Georgia, 30901
Hematology Oncology Centers of the Northern Rockies, PC
Billings, Montana, 59101
Tri-County Hematology and Oncology Associates
Canton, Ohio, 44718
Cancer Specialists of Tidewater, Ltd.
Chesapeake, Virginia, 23320
Oncology-Hematology Associates, P.A.
Clinton, Maryland, 20735
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814
Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43215
Wilshire Oncology Medical Group, Inc.
La Verne, California, 91750
Arena Oncology Associates
Lake Success, New York, 11042
Lancaster Cancer Center, Ltd.
Lancaster, Pennsylvania, 17605
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060
The West Clinic
Memphis, Tennessee, 38120
Advanced Medical Specialties
Miami, Florida, 33176
Medical Oncology & Hematology
Waterbury, Connecticut, 06708
About this study
Official title: A Phase II, Open Label Study Evaluating an Alternative Schedule of Velcade/Dexamethasone Plus Doxil in the Treatment of Multiple Myeloma
The current study is being conducted to evaluate the possibility that a different schedule of bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib dosing for a longer period.
- Conditions
- Multiple Myeloma
- Being tested
- bortezomib, dexamethasone, doxorubicin HCl liposome
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Also called Velcade
Patients will be treated with bortezomib at 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days (cycle).
dexamethasoneDrug
Also called Decadron
Dexamethasone tablets will be given at 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days (cycle).
doxorubicin HCl liposomeDrug
Also called Doxil
Patients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m^2 on Day 4 every 28 days (cycle).
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Peripheral Neuropathy
Measured: Every 4 weeks from start of treatment until end of treatment
Secondary outcomes (3)
Time to Progression (TTP)
Measured: TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months
Number of Participants With Treatment Response
Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and <5% plasma cells in bone marrow. PR also required >=50% SPEP reduction, >=90% UPEP reduction, and >=50% reduction in plasma cells in bone marrow. MR also required >=25% SPEP reduction, >=50% UPEP reduction, and > 25% reduction in plasma cells.
Measured: Every 8 weeks from start of treatment until end of treatment
Relative Dose Intensity of Bortezomib
Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.
Measured: Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Study was closed to enrollment when it became clear that enrollment was too slow to complete full enrollment target within time frame allowed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accelerated Community Oncology Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Johnetta Blakely, MD, Principal investigator, Accelerared Community Oncology Research Network, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366106
- Sponsor's protocol ID
- ACORN ALJBMM0502
- Status last verified
- Apr 2012
- First submitted
- 16 Aug 2006
- Last updated
- 6 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label Study Evaluating an Alternative Schedule of Velcade/Dexamethasone Plus Doxil in the Treatment of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00366106
- Acronym / sponsor ID
- ACORN ALJBMM0502
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed to enrollment when it became clear that enrollment was too slow to complete full enrollment target within time frame allowed.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Accelerated Community Oncology Research NetworkUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Jul 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 18 Aug 2006 (estimated)
- Results
- Posted 5 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study is being conducted to evaluate the possibility that a different schedule of bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib dosing for a longer period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is at least 18 years of age.
- Patient has confirmed diagnosis of relapsed/refractory multiple myeloma with measurable disease by serum or urine. Measurable disease defined as monoclonal protein of ≥ 1g/dl on serum protein electrophoresis (SPEP) or > 200 mg urine M protein/ 24 hours
- Patient has received at least 1 prior treatment regimen. (Prior treatment with bortezomib is allowed.)
- Patient has ECOG ≤ 2
- Patient provides voluntary written informed consent before performance of any study-relates procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Key exclusion criteria (16 listed)
- Patient has a platelet count of < 50, 000 cells/mm³, within 14 days before enrollment.
- Patient has an absolute neutrophil count (ANC) ≤ 750/mm³ within 14 days before enrollment.
- Patient has a calculated or measured creatinine clearance of < 20 mL/min within 14 days before enrollment and/or serum creatinine ≥ 2.5 mg/dl.
- Patient has hemoglobin < 7.5 g/dl.
- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomibAlso: VelcadePatients will be treated with bortezomib at 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days (cycle). | Drug | – |
| dexamethasoneAlso: DecadronDexamethasone tablets will be given at 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days (cycle). | Drug | – |
| doxorubicin HCl liposomeAlso: DoxilPatients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m^2 on Day 4 every 28 days (cycle). | Drug | – |
Primary outcome
Incidence of Treatment-emergent Peripheral Neuropathy
Time frame: Every 4 weeks from start of treatment until end of treatment
3 secondary outcomes
Time to Progression (TTP)
Time frame: TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months
Number of Participants With Treatment Response
Time frame: Every 8 weeks from start of treatment until end of treatment
Relative Dose Intensity of Bortezomib
Time frame: Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnetta Blakely, MD principal investigator
Accelerared Community Oncology Research Network, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib, dexamethasone and doxorubicin HCl liposome in people with Multiple Myeloma, run by Accelerated Community Oncology Research Network at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-emergent Peripheral Neuropathy (time frame: Every 4 weeks from start of treatment until end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.