Stage I Multiple MyelomaPhase 2NCT00075881
Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma
A Phase 2 study testing bortezomib and laboratory biomarker analysis in people with Stage I Multiple Myeloma and Stage II Multiple Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial studies how well bortezomib works in treating patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- What is being tested?
- bortezomib and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Oct 2012
- 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
- Patients must not have received prior myeloma specific therapy (chemotherapy, radiotherapy, or biologic therapy) other than bisphosphonate therapy
- Patients may have received radiation of plasmacytoma (for example, solitary plasmacytoma); the last such treatment must have occurred >= 4 weeks prior to registration
- Patients must be recently diagnosed with symptomatic multiple myeloma confirmed by meeting one or more of the following criteria (obtained =< 30 days prior to registration):
- NOTE: serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP) and marrow biopsy all must be done at baseline in order to evaluate response
- Monoclonal protein in the serum >= 1 g/dl (measurable disease), or
- Monoclonal light chain in the urine protein electrophoresis >= 200 mg/24 hours (measurable disease), or
Show all 37Show fewer
- Bone marrow plasmacytosis >= 30% without either of the values in above (evaluable disease)
- Patients must meet one or more of the following (all tests must be been drawn =< 30 days prior to registration but all results are not required to be available at time of registration as long as at least one of the following criteria has been met; if patient is otherwise eligible, plasma cell labeling index [PCLI] is not required, but is requested):
- Beta-2 microglobulin >= 5.5 mcg/mL, or
- PCLI >= 1, or
- Deletion 13 by cytogenetics
- Platelet count >= 20,000/mm^3, with or without transfusion support
- Hemoglobin >= 7.0 g/dL, with or without transfusion support
- Absolute neutrophil count (ANC) >= 500/mm^3 without growth factor support
- Direct bilirubin within =< 1.5 x upper normal limits (UNL)
- Alkaline phosphatase =< 2.5 x UNL
- Aspartate aminotransferase (AST) =< 2.5 x UNL
- Calculated or measured creatinine clearance >= 20 mL/minute
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2; exception: PS = 3 if secondary to acute bone event (fracture)
- Patients may not receive concurrent chemotherapy, radiotherapy or biologic therapy while on study; the exception for corticosteroids is made for those taking chronic corticosteroids for disorders other than myeloma, such as rheumatoid arthritis, adrenal insufficiency, etc.
- NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
- Patients must not have a history of allergic reaction attributable to compounds containing boron or mannitol
- Patient must not have a peripheral neuropathy > grade 1, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 3.0):
- Grade 2: Objective sensory (or motor) loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADL)
- Grade 3: Sensory (or motor) loss or paresthesia interfering with ADL
- Grade 4: Permanent sensory (or motor) loss that interferes with function
- Patient must be capable of understanding the investigational nature, potential risks and benefits of the study
- Patient must have adequate cardiac function; patient must not have:
- History of a myocardial infarction within 6 months of enrollment
- New York Heart Association (NYHA) class III or IV heart failure
- Uncontrolled angina or electrocardiographic evidence of acute ischemia
- Severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of active conduction system abnormalities
- Cardiac amyloidosis
- Patient must not have any other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
- Patient must not have poorly controlled hypertension
- Women must not be pregnant or breast feeding; all females of childbearing potential must have a blood test or urine study within 7 days prior to registration to rule out pregnancy
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215
About this study
Official title: Phase II Study of PS-341 for Patients With High-Risk, Newly Diagnosed Multiple Myeloma
This phase II trial studies how well bortezomib works in treating patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the response rate to PS-341 (bortezomib) induction in patients with high risk, newly diagnosed multiple myeloma.
SECONDARY OBJECTIVES:
- To evaluate progression free survival. II. To explore the response rate of patients who relapse or progress on maintenance and then return to induction schedule.
III. To explore duration of second response.
TERTIARY OBJECTIVES:
- To explore a possible differential response to PS-341 with previously described adverse prognostic indicators.
II. To explore specific gene expression profiles (GEP) that may predict response to therapy to an agent or combination of agents used in the treatment of newly diagnosed myeloma.
III. To explore specific post-treatment gene expression profiles (GEP) in the patients who have received 4 cycles of therapy and achieved a minimal response or better.
IV. To develop relevant information about the immune system for multiple myeloma patients treated with PS-341.
OUTLINE:
INDUCTION TREATMENT: Patients receive bortezomib intravenously (IV) on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TREATMENT: Patients who complete induction treatment without progressive disease receive bortezomib IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
REINDUCTION TREATMENT: Patients who progress while on maintenance treatment receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 4 years.
- Being tested
- bortezomib, laboratory biomarker analysis
- 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 LDP 341, MLN341, VELCADE
Given IV
laboratory biomarker analysisOther
Optional correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (bortezomib) | Experimental | INDUCTION TREATMENT: Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TREATMENT: Patients who complete induction treatment without progressive disease receive bortezomib IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
REINDUCTION TREATMENT: Patients who progress while on maintenance treatment receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: bortezomib; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate on Induction
Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.
Measured: participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days
Secondary outcomes (3)
Response Rate on Maintenance
ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 15 eligible and treated patients were included in the analysis.
Measured: participants were evaluated prior to each cycle, up to 45 cycles with a median number of 9 cycles. 1 cycle=21 days
Response Rate on Reinduction
ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 7 eligible and treated patients were included in the analysis.
Measured: participants were evaluated prior to each cycle, up to 23 cycles with a median number of 3 cycles. 1 cycle=21 days
1-year Progression Free Survival Probability
Progression-free survival is defined as time from randomization to disease progression or death from any cause, whichever occurred first. Disease progression is defined using the ECOG Myeloma Response Criteria. Kaplan-Meier method is used to estimate the 1-year progression-free survival probability. 42 eligible and treated patients were included in the analysis.
Measured: Every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-6 years from study entry, no specific requirment if patient is more than 6 years from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2004 (estimated)
- Study startJan 2004
- Primary completionOct 2012
- Study completionOct 2012
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 Stage I Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Angela Dispenzieri, Principal investigator, Eastern Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075881
- Sponsor's protocol ID
- NCI-2014-00652
- Other IDs
- NCI-2014-00652, CDR0000349450, E2A02, E2A02, U10CA021115
- Status last verified
- Mar 2014
- First submitted
- 9 Jan 2004
- Last updated
- 2 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of PS-341 for Patients With High-Risk, Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00075881
- Acronym / sponsor ID
- NCI-2014-00652
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2004
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Jan 2004 (estimated)
- Results
- Posted 28 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well bortezomib works in treating patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the response rate to PS-341 (bortezomib) induction in patients with high risk, newly diagnosed multiple myeloma.
SECONDARY OBJECTIVES:
- To evaluate progression free survival. II. To explore the response rate of patients who relapse or progress on maintenance and then return to induction schedule.
III. To explore duration of second response.
TERTIARY OBJECTIVES:
- To explore a possible differential response to PS-341 with previously described adverse prognostic indicators.
II. To explore specific gene expression profiles (GEP) that may predict response to therapy to an agent or combination of agents used in the treatment of newly diagnosed myeloma.
III. To explore specific post-treatment gene expression profiles (GEP) in the patients who have received 4 cycles of therapy and achieved a minimal response or better.
IV. To develop relevant information about the immune system for multiple myeloma patients treated with PS-341.
OUTLINE:
INDUCTION TREATMENT: Patients receive bortezomib intravenously (IV) on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TREATMENT: Patients who complete induction treatment without progressive disease receive bortezomib IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
REINDUCTION TREATMENT: Patients who progress while on maintenance treatment receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (bortezomib) | Experimental | Drug: bortezomib, Other: laboratory biomarker analysisINDUCTION TREATMENT: Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE TREATMENT: Patients who complete induction treatment without progressive disease receive bortezomib IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. REINDUCTION TREATMENT: Patients who progress while on maintenance treatment receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Patients must not have received prior myeloma specific therapy (chemotherapy, radiotherapy, or biologic therapy) other than bisphosphonate therapy
- Patients must be recently diagnosed with symptomatic multiple myeloma confirmed by meeting one or more of the following criteria (obtained =< 30 days prior to registration):
- Patients must meet one or more of the following (all tests must be been drawn =< 30 days prior to registration but all results are not required to be available at time of registration as long as at least one of the following criteria has been met; if patient is otherwise eligible, plasma cell labeling index [PCLI] is not required, but is requested):
- Platelet count >= 20,000/mm^3, with or without transfusion support
- Hemoglobin >= 7.0 g/dL, with or without transfusion support
Key exclusion criteria (0 listed)
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: LDP 341, MLN341, VELCADEGiven IV | Drug | Treatment (bortezomib) |
| laboratory biomarker analysisOptional correlative studies | Other | Treatment (bortezomib) |
Primary outcome
Response Rate on Induction
Time frame: participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days
Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.
3 secondary outcomes
Response Rate on Maintenance
Time frame: participants were evaluated prior to each cycle, up to 45 cycles with a median number of 9 cycles. 1 cycle=21 days
Response Rate on Reinduction
Time frame: participants were evaluated prior to each cycle, up to 23 cycles with a median number of 3 cycles. 1 cycle=21 days
1-year Progression Free Survival Probability
Time frame: Every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-6 years from study entry, no specific requirment if patient is more than 6 years from study entry
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
- 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.
Angela Dispenzieri principal investigator
Eastern Cooperative Oncology Group
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 and laboratory biomarker analysis in people with Stage I Multiple Myeloma and Stage II Multiple Myeloma, run by National Cancer Institute (NCI) 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 37 inclusion and 0 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: finished, as of the sponsor's last update on 2 Jun 2014. 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 28 Sep 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?
Response Rate on Induction (time frame: participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days). 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 2 Jun 2014.