Multiple MyelomaPhase 2NCT01062230
Bone Effect of Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma
A Phase 2 study testing Bortezomib (Velcade) in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
The primary aim of this trial is to determine the effect of a short course (i.e., 3 cycles) of low-dose Bortezomib (Velcade) on bone remodeling and on disease progression. The dose of bortezomib used in this trial of 0.7 mg/m2 is the lowest dose which has shown efficacy in the 3 largest monotherapy trials with… 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 (Velcade)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 2013
- 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
- History of histologically documented MM with relapsed or progressive disease after at least one line of prior therapy.
- Patient has measurable disease in which to capture response, defined as one or more of the following:
- Serum M-protein level > 1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis; or
- Urinary M-protein excretion > 200 mg/24 hrs; or
- Bone marrow plasmacytosis of > 30% by bone marrow aspirate and/or biopsy; or
- Serum Free Light Chains (By the Freelite test) > 2X ULN, in the absence of renal failure
Show all 16Show fewer
- Radiographic evidence of disease
- Performance status of < 2 as per ECOG scale, unless PS of 3-4 based solely on bone pain.
- Patients must have a platelet count > 100,000/L and an ANC of at least 1,000/μl.
- Patients must have adequate renal function defined as serum creatinine ≤2.5 mg/dL.
- Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 3 x the upper limit of normal.
- Male or female adults of at least 18 years of age.
- Voluntary written informed consent before performance of any study-related 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.
- 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.
- Growth factors are allowed during the study
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
Who cannot join
- Platelet count of <100x 10(9)/L within 14 days before enrollment.
- Absolute neutrophil count (ANC) <1.0 x 10(9)/L
- Serum creatinine ≥ 2.5 mg/dL within 14 days before enrollment.
- Patient has >Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 1.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
Show all 17Show fewer
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Chemotherapy or radiotherapy received within the previous 4 weeks of study enrollment.
- 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 (beta-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 with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- POEMS Syndrome
- Clinically significant hepatic dysfunction as noted by bilirubin or AST > 3 times the upper normal limit or clinically significant concurrent hepatitis.
- Uncontrolled, active infection
- Patients that have taken bisphosphonates within 30 days of screening will not be eligible for this trial.
- Must not have received VELCADE 90 days prior to enrolling in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this trial is to determine the effect of a short course (i.e., 3 cycles) of low-dose Bortezomib (Velcade) on bone remodeling and on disease progression. The dose of bortezomib used in this trial of 0.7 mg/m2 is the lowest dose which has shown efficacy in the 3 largest monotherapy trials with bortezomib. 17% of patients in the APEX, 9% patients in CREST and 24% in SUMMIT trials were treated with 0.7 mg/m2 dosages. Bortezomib will be given on days 1, 8, 15, 22 over 42 days to reduce the incidence of possible drug related side effects.
OBJECTIVES:
Read more
Primary Objective
The primary objective of this study is to:
- To evaluate the effect of Velcade at 0.7 mg/m2 dose on inducing osteoblast activation as measured by ALP and other bone markers in patients with relapsed/refractory myeloma.
Secondary Objectives
The secondary objectives of this study are to:
- To evaluate the association between osteoblastic activation and myeloma response to Velcade.
- To identify predictive factors for Velcade-associated osteoblastic activation.
Read the detailed description
Multiple myeloma (MM) accounts for approximately 1% of all malignancies and 10% of hematological tumors, representing the second most frequently occurring hematological malignancy in the United States. At any one time, 50,000 people suffer from MM, and approximately 15,000 are diagnosed each year. The median age is approximately 65 years, although occasionally MM occurs in the second decade of life. Myeloma is a disease of neoplastic plasma cells that synthesize abnormal amounts of immunoglobulin or immunoglobulin fragments. Myeloma is the only hematological malignancy associated with bone disease. Myeloma is a B-cell neoplasia characterized by clonal expansion of plasma cells in the bone marrow. It is the most malignant stage of plasma cell dyscrasias, which also include the precursor stages of MGUS and indolent or smoldering myeloma. Myeloma is frequently associated with lytic bone disease that is responsible for the most debilitating manifestations of the disease, including bone pain and fractures.
Bone disease in myeloma results from the activation of osteoclast and suppression of osteoblast activity in the myelomatous bone marrow. Change in bone turnover rates, expressed as increased osteoblastic and osteoclastic activity, precede the progression pf MGUS or smoldering myeloma to overt myeloma by as long as three years.
Treatment with bisphosphonates reduces bone resorption and also to some degree, bone formation, and over the long-term moderately increases bone density. Other approved antiresorptive therapies have been shown to reduce the risk of fracture in osteoporotic women, but none have been shown to restore normal bone mass or strength. As a result, treatments that directly stimulate bone formation may overcome these limitations, increase bone mass, and improve the quality of life of myeloma patients. Bone disease is responsible for the most severe complications associated with multiple myeloma. As treatment and survival of myeloma patients improve, new therapies to improve complications are important and vitally needed VELCADE™ (bortezomib) for Injection is a small molecule proteasome inhibitor developed by Millennium Pharmaceuticals, Inc., (Millennium) as a novel agent to treat human malignancies. VELCADE is currently approved by the United States Food and Drug Administration (US FDA) and it is registered in Europe for the treatment of multiple myeloma patients who have received at least one prior therapy.
The clinical response to bortezomib observed in a 63-year-old woman with multiple myeloma and the parallel increase in alkaline phosphatase (ALP) has led us and other groups to evaluate the correlation between bone anabolism and myeloma response to bortezomib. After similar elevations were noted in patients responding to bortezomib, thalidomide, dexamethasone combination, ALP levels were analysed in two large bortezomib trials (Roodman, 2008). Giuliani and coworkers (2007) found that bortezomib significantly increased the activity of the critical osteoblast transcription factor, RUNX2, in human osteoblast precursors and stimulated bone nodule formation in vitro. Importantly, they found a significant increase in the number of osteoblasts per mm2 of bone tissue and the number of RUNX2 positive osteoblastic cells in marrow biopsies from myeloma patients that responded to bortezomib. Again, the effect on osteoblasts was only seen in patients whose myeloma responded to bortezomib, making it difficult to distinguish if the increase in osteoblast activity was due to the anti-myeloma effects of bortezomib or direct effects on osteoblasts or both. Terpos and colleagues (2006) have reported that bortezomib also decreased DKK1 and RANKL concentrations and normalized bone remodeling indices in the serum of patients with relapsed myeloma. However, the majority of patients that showed an increase in bone formation markers also showed an antitumor response to bortezomib, making it unclear if the stimulatory effects on bone formation were secondary to the effects of bortezomib on myeloma or due to direct effects on osteoblast differentiation After similar elevations were noted in patients responding to bortezomib, thalidomide, dexamethasone combination, ALP levels were analysed in two large bortezomib trials.
We first completed a retrospective analysis of large Phase 3 trials comparing ALP levels in responders (≥PR) vs nonresponders (≤PR) patients.
Data obtained from the APEX Crest and Summit protocols, have shown that a total of 85 myeloma patients were treated with bortezomib at the dose of 0.7 mg/m2 for different reasons with significant antimyeloma efficacy for multiple cycles. This dose (0.7 mg/m2) will be used in this trial to test if the antimyeloma activity of bortezomib is still associated to bone anabolic effect. Data for the APEX, summit, and CREST trials is on file at Millennium Pharmaceuticals.
Given that this study is a continuation of a previous protocol (UARK 2004-22) when at the dose of 1.3 and 1.0 mg/m2 an antimyeloma effect and associated bone formation were observed. This trial will test the effect of 0.7 mg/m2 (which has been shown to be effective on antimyeloma treatment) on bone formation to determine the minimal dose associated to bone effect.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib (Velcade)
- Keywords
- Cancer, Hematologic malignancy
- Medical subject headings
- Multiple Myeloma, Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib (Velcade)Drug
Also called Velcade
Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.
Patients will undergo three 21-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All participants enrolled. Receives: Drug: Bortezomib (Velcade) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1
All patients received 0.7 mg/m2 of bortezomib on days 1, 4, 8 and 11 of a 21 day cycle, for maximum of three cycles for an average of 18 months. Intact Parathyroid hormone was measured in patients with relapsed/refractory myeloma for osteoblast activation. Other bone markers were examined using similar methods.
Measured: Baseline and Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Slow accrual; PI left primary institution
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.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Maurizio Zangari, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062230
- Sponsor's protocol ID
- HCI35813
- Status last verified
- Apr 2015
- First submitted
- 2 Feb 2010
- Last updated
- 6 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Effect of Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01062230
- Acronym / sponsor ID
- HCI35813
- Conditions
- Multiple Myeloma
- Keywords
- Cancer, Hematologic malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual; PI left primary institution
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Jan 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Posted 6 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this trial is to determine the effect of a short course (i.e., 3 cycles) of low-dose Bortezomib (Velcade) on bone remodeling and on disease progression. The dose of bortezomib used in this trial of 0.7 mg/m2 is the lowest dose which has shown efficacy in the 3 largest monotherapy trials with bortezomib. 17% of patients in the APEX, 9% patients in CREST and 24% in SUMMIT trials were treated with 0.7 mg/m2 dosages. Bortezomib will be given on days 1, 8, 15, 22 over 42 days to reduce the incidence of possible drug related side effects.
OBJECTIVES:
Primary Objective
The primary objective of this study is to:
- To evaluate the effect of Velcade at 0.7 mg/m2 dose on inducing osteoblast activation as measured by ALP and other bone markers in patients with relapsed/refractory myeloma.
Secondary Objectives
The secondary objectives of this study are to:
- To evaluate the association between osteoblastic activation and myeloma response to Velcade.
- To identify predictive factors for Velcade-associated osteoblastic activation.
Detailed description
Multiple myeloma (MM) accounts for approximately 1% of all malignancies and 10% of hematological tumors, representing the second most frequently occurring hematological malignancy in the United States. At any one time, 50,000 people suffer from MM, and approximately 15,000 are diagnosed each year. The median age is approximately 65 years, although occasionally MM occurs in the second decade of life. Myeloma is a disease of neoplastic plasma cells that synthesize abnormal amounts of immunoglobulin or immunoglobulin fragments. Myeloma is the only hematological malignancy associated with bone disease. Myeloma is a B-cell neoplasia characterized by clonal expansion of plasma cells in the bone marrow. It is the most malignant stage of plasma cell dyscrasias, which also include the precursor stages of MGUS and indolent or smoldering myeloma. Myeloma is frequently associated with lytic bone disease that is responsible for the most debilitating manifestations of the disease, including bone pain and fractures.
Bone disease in myeloma results from the activation of osteoclast and suppression of osteoblast activity in the myelomatous bone marrow. Change in bone turnover rates, expressed as increased osteoblastic and osteoclastic activity, precede the progression pf MGUS or smoldering myeloma to overt myeloma by as long as three years.
Treatment with bisphosphonates reduces bone resorption and also to some degree, bone formation, and over the long-term moderately increases bone density. Other approved antiresorptive therapies have been shown to reduce the risk of fracture in osteoporotic women, but none have been shown to restore normal bone mass or strength. As a result, treatments that directly stimulate bone formation may overcome these limitations, increase bone mass, and improve the quality of life of myeloma patients. Bone disease is responsible for the most severe complications associated with multiple myeloma. As treatment and survival of myeloma patients improve, new therapies to improve complications are important and vitally needed VELCADE™ (bortezomib) for Injection is a small molecule proteasome inhibitor developed by Millennium Pharmaceuticals, Inc., (Millennium) as a novel agent to treat human malignancies. VELCADE is currently approved by the United States Food and Drug Administration (US FDA) and it is registered in Europe for the treatment of multiple myeloma patients who have received at least one prior therapy.
The clinical response to bortezomib observed in a 63-year-old woman with multiple myeloma and the parallel increase in alkaline phosphatase (ALP) has led us and other groups to evaluate the correlation between bone anabolism and myeloma response to bortezomib. After similar elevations were noted in patients responding to bortezomib, thalidomide, dexamethasone combination, ALP levels were analysed in two large bortezomib trials (Roodman, 2008). Giuliani and coworkers (2007) found that bortezomib significantly increased the activity of the critical osteoblast transcription factor, RUNX2, in human osteoblast precursors and stimulated bone nodule formation in vitro. Importantly, they found a significant increase in the number of osteoblasts per mm2 of bone tissue and the number of RUNX2 positive osteoblastic cells in marrow biopsies from myeloma patients that responded to bortezomib. Again, the effect on osteoblasts was only seen in patients whose myeloma responded to bortezomib, making it difficult to distinguish if the increase in osteoblast activity was due to the anti-myeloma effects of bortezomib or direct effects on osteoblasts or both. Terpos and colleagues (2006) have reported that bortezomib also decreased DKK1 and RANKL concentrations and normalized bone remodeling indices in the serum of patients with relapsed myeloma. However, the majority of patients that showed an increase in bone formation markers also showed an antitumor response to bortezomib, making it unclear if the stimulatory effects on bone formation were secondary to the effects of bortezomib on myeloma or due to direct effects on osteoblast differentiation After similar elevations were noted in patients responding to bortezomib, thalidomide, dexamethasone combination, ALP levels were analysed in two large bortezomib trials.
We first completed a retrospective analysis of large Phase 3 trials comparing ALP levels in responders (≥PR) vs nonresponders (≤PR) patients.
Data obtained from the APEX Crest and Summit protocols, have shown that a total of 85 myeloma patients were treated with bortezomib at the dose of 0.7 mg/m2 for different reasons with significant antimyeloma efficacy for multiple cycles. This dose (0.7 mg/m2) will be used in this trial to test if the antimyeloma activity of bortezomib is still associated to bone anabolic effect. Data for the APEX, summit, and CREST trials is on file at Millennium Pharmaceuticals.
Given that this study is a continuation of a previous protocol (UARK 2004-22) when at the dose of 1.3 and 1.0 mg/m2 an antimyeloma effect and associated bone formation were observed. This trial will test the effect of 0.7 mg/m2 (which has been shown to be effective on antimyeloma treatment) on bone formation to determine the minimal dose associated to bone effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: Bortezomib (Velcade)All participants enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- History of histologically documented MM with relapsed or progressive disease after at least one line of prior therapy.
- Patient has measurable disease in which to capture response, defined as one or more of the following:
- Performance status of < 2 as per ECOG scale, unless PS of 3-4 based solely on bone pain.
- Patients must have a platelet count > 100,000/L and an ANC of at least 1,000/μl.
- Patients must have adequate renal function defined as serum creatinine ≤2.5 mg/dL.
Key exclusion criteria (17 listed)
- Platelet count of <100x 10(9)/L within 14 days before enrollment.
- Absolute neutrophil count (ANC) <1.0 x 10(9)/L
- Serum creatinine ≥ 2.5 mg/dL within 14 days before enrollment.
- Patient has >Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 1.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
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 |
|---|---|---|
| Bortezomib (Velcade)Also: VelcadeBortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles. Patients will undergo three 21-day cycles. | Drug | All patients |
Primary outcome
Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1
Time frame: Baseline and Day 1
All patients received 0.7 mg/m2 of bortezomib on days 1, 4, 8 and 11 of a 21 day cycle, for maximum of three cycles for an average of 18 months. Intact Parathyroid hormone was measured in patients with relapsed/refractory myeloma for osteoblast activation. Other bone markers were examined using similar methods.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
- 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.
Maurizio Zangari, MD principal investigator
University of Arkansas
1 site 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 (Velcade) in people with Multiple Myeloma, run by University of Arkansas at 1 site 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 16 inclusion and 17 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 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 6 Apr 2015). 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?
Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1 (time frame: Baseline and Day 1). 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 2015.