Multiple MyelomaPhase 2RENVELNCT01084837
Study of Induction Treatment With Velcade and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal Failure
A Phase 2 study testing velcade in people with Multiple Myeloma, run by PETHEMA Foundation at 11 sites in Spain.
Trial summary
Primary outcome measure: Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone treatment Secondary outcome measures: Study the speed of response and the response rate (M component in serum and urine protein) after each bortezomib/dexamethasone cycle Compare the efficacy of the… 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?
- velcade
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 11 sitesSpain
- Study dates
- Mar 2010to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- The patient must, according with investigator criteria, be able to comply with all the protocol requirements
- The patient or legal representative must sign voluntarily the informed consent before the performance of any study related procedure, not part of usual medical care, with the knowledge that can leave the study the moment he/she wants, without prejudice to later medical care
- 18 years and older
- Patients with newly diagnosed symptomatic multiple myeloma43 which hasn't been treated previously with any chemotherapy used for this disease (see Annex 8)
- Patient with a measurable or evaluable disease, defined as follows:
- For secretor multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value of IgG>10g/l or IgA > 5 g/l and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours
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- For oligo or non-secretor multiple myeloma, measurable disease is defined by the presence of soft tissue plasmocytomas (not bone) determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with low secretor multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessment. In patients with non-secretor multiple myeloma, there is no M-protein in serum or urine by immunofixation
- ECOG performance status ≤ 2 (see Appendix 5)
- Patient has a life-expectancy >3 months
- Glomerular filtration calculated with MDRD <50 ml/min
- Patient has the following laboratory values during the 14 days before first dose:
- Platelet count ≥ 50x109/l
- Absolute neutrophil count (ANC) ≥ 0.75 x 10 9/ L
- Corrected serum calcium (see Appendix 15) ≤ 14mg/dl
- Aspartate transaminase (AST): ≤ 2,5 x upper limit of normal
- Alanine Aminotransferase (ALT): ≤ 2,5 x upper limit of normal
- Total bilirubin: ≤ 1,5 x upper limit of normal
Who cannot join
- Glomerular filtration calculated with MDRD ≥ 50ml/min
- Asymptomatic MM with renal failure from unrelated causes
- Prior Velcade therapy
- Patients previously received treatment to Multiple Myeloma
- Patient had major surgery within 4 weeks previous inclusion
- Patient with platelet count ≤ 50 x 109/l within 14 days before enrolment
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- Patient with absolute neutrophil count ≤ 0,75x109/l within 14 days before enrolment
- Patients with Grade 2 peripheral neuropathy within 14 days before enrolment
- Patient has hypersensitivity to bortezomib, boron or mannitol
- Patient has received other investigational drugs within 14 days before enrolment
- Patient is known to be seropositive for the human immunodeficiency virus (HIV)
- Patient had a myocardial infarction within 6 months before of enrolment or has Class III or IV heart failure (New York Heart Association <NYHA>), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiography evidence of acute ischemia or active conduction system abnormalities, or other heart condition which, according with the specialist, can result in heart failure
- Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason
- Patients with diffuse pulmonary disease and/or pericardial disease
- Pregnancy or breast-feed women and women of childbearing age that don't accept to use anticonceptive methods since beginning during all the study until 30 days after last cycle treatment. Fertile male patients must use effective form of contraception since enrolment, during and until 30 days after last cycle study treatment
- Patient with a previous clinical history of another malign illness except for squamous cell carcinoma or skin cancer or cervical or breast cancer) except the patient could be free of symptoms during ≥ 5 years
- Uncontrolled arterial hypertension or diabetes mellitus or other serious medical condition which places the subject at unacceptable risk or other psychiatric illness that would prevent the subject from understanding the informed consent form
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona
Hospital Clinic
Barcelona, Barcelona
Hospital de Sant Pau
Barcelona, Barcelona
Hospital 12 de Octubre
Madrid, Madrid
Hospital Clínico San Carlos
Madrid, Madrid
Hospital Ramón y Cajal
Madrid, Madrid
Hospital Universitario
Salamanca, Salamanca
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife
Hospital General
Segovia, Segovia
Hospital La Fe
Valencia, Valencia
Hospital Lozano Blesa
Zaragoza, Zaragoza
About this study
Official title: A National, Multicentric, Open-label Study of Induction Treatment With VELCADE and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal Failure
Primary outcome measure:
- Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone treatment
Read more
Secondary outcome measures:
- Study the speed of response and the response rate (M component in serum and urine protein) after each bortezomib/dexamethasone cycle
- Compare the efficacy of the bortezomib/dexamethasone therapy against the therapy without bortezomib
- Reversibility of renal failure
- Predictive value in the light chain determination for response and reversibility of renal failure
- Early morbidity (< 2 months)
- Progression-free survival
- Overall survival
The safety outcome consists in:
- Determining the safety and tolerance of VELCADE/Dexamethasone, according to the toxicity criteria of clinical and laboratory events
Read the detailed description
60 patients, 18 years or older, diagnosed with newly symptomatic multiple myeloma (standard diagnosis criteria) and renal failure, previously untreated with chemotherapy, will be included.
It is an multi centric, national and open study designed in order to determine efficacy of the combination of bortezomib and dexamethasone for multiple myeloma patients with renal failure.
The trial consists of two parts: pre-treatment and treatment. Pre- treatment phase: include the enrolment visit in order to determine that the patient is eligible to participate in a study. The patient will be given the Informed Consent Form in order to participate in the study, and detailed information about the treatment, its benefits and risks.
Treatment phase: include the treatment which consist of, at the most, 12 cycles of Velcade and Dexamethasone (induction and extension). During these periods, patients will come to the centre for the study visits to be evaluated, the days they will receive Velcade® of each cycle.
Once the clinical trial has finished, patients will be monitored during short and long-term periods where progression free survival and overall survival will be evaluated.
- Conditions
- Multiple Myeloma
- Being tested
- velcade
- Keywords
- Multiple myeloma, Renal failure
- Medical subject headings
- Multiple Myeloma, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
velcadeDrug
INDUCTIoN (Cycles 1-4)
- Bortezomib 1,3 mg/m2 i.v. days 1, 4, 8 and 11 follow by 10 days without treatment
- Dexamethasone 40 mg/p.o. days 1-4 and 9-12 cycles 1-4 (Cycles of 21 days)
For patients wich is not planned autotransplantation, add:
Cycles 5-8
- Bortezomib 1,3 mg/m2 i.v. days 1, 4, 8 and 11 follow by 10 days without treatment
- Dexamethasone 40 mg/v.o. days 1-4 (Cycles of 21 days)
EXTENSION TREATMENT(Cycles 9-12)
- Bortezomib 1,3 mg/m2 i.v. days 1, 8, 15 and 22
- Dexamethasone 40 mg/d v.o. days 1-4 (Every 6 weeks)
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone treatment
Measured: 2 years
Secondary outcomes (3)
Progression-free survival
Measured: 2 years
Overall survival
Measured: 4 years
Safety
Determining the safety and tolerance of VELCADE/Dexamethasone, according to the toxicity criteria of clinical and laboratory events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084837
- Sponsor's protocol ID
- RENVEL
- Acronym
- RENVEL
- Status last verified
- Sep 2015
- First submitted
- 7 Mar 2010
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Multicentric, Open-label Study of Induction Treatment With VELCADE and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal Failure
- ClinicalTrials.gov ID
- NCT01084837
- Acronym / sponsor ID
- RENVEL / RENVEL
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Renal failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary outcome measure:
- Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone treatment
Secondary outcome measures:
- Study the speed of response and the response rate (M component in serum and urine protein) after each bortezomib/dexamethasone cycle
- Compare the efficacy of the bortezomib/dexamethasone therapy against the therapy without bortezomib
- Reversibility of renal failure
- Predictive value in the light chain determination for response and reversibility of renal failure
- Early morbidity (< 2 months)
- Progression-free survival
- Overall survival
The safety outcome consists in:
- Determining the safety and tolerance of VELCADE/Dexamethasone, according to the toxicity criteria of clinical and laboratory events
Detailed description
60 patients, 18 years or older, diagnosed with newly symptomatic multiple myeloma (standard diagnosis criteria) and renal failure, previously untreated with chemotherapy, will be included.
It is an multi centric, national and open study designed in order to determine efficacy of the combination of bortezomib and dexamethasone for multiple myeloma patients with renal failure.
The trial consists of two parts: pre-treatment and treatment. Pre- treatment phase: include the enrolment visit in order to determine that the patient is eligible to participate in a study. The patient will be given the Informed Consent Form in order to participate in the study, and detailed information about the treatment, its benefits and risks.
Treatment phase: include the treatment which consist of, at the most, 12 cycles of Velcade and Dexamethasone (induction and extension). During these periods, patients will come to the centre for the study visits to be evaluated, the days they will receive Velcade® of each cycle.
Once the clinical trial has finished, patients will be monitored during short and long-term periods where progression free survival and overall survival will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (17 listed)
- The patient must, according with investigator criteria, be able to comply with all the protocol requirements
- The patient or legal representative must sign voluntarily the informed consent before the performance of any study related procedure, not part of usual medical care, with the knowledge that can leave the study the moment he/she wants, without prejudice to later medical care
- 18 years and older
- Patients with newly diagnosed symptomatic multiple myeloma43 which hasn't been treated previously with any chemotherapy used for this disease (see Annex 8)
- Patient with a measurable or evaluable disease, defined as follows:
Key exclusion criteria (17 listed)
- Glomerular filtration calculated with MDRD ≥ 50ml/min
- Asymptomatic MM with renal failure from unrelated causes
- Prior Velcade therapy
- Patients previously received treatment to Multiple Myeloma
- Patient had major surgery within 4 weeks previous inclusion
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 |
|---|---|---|
| velcadeINDUCTIoN (Cycles 1-4) * Bortezomib 1,3 mg/m2 i.v. days 1, 4, 8 and 11 follow by 10 days without treatment * Dexamethasone 40 mg/p.o. days 1-4 and 9-12 cycles 1-4 (Cycles of 21 days) For patients wich is not planned autotransplantation, add: Cycles 5-8 * Bortezomib 1,3 mg/m2 i.v. days 1, 4, 8 and 11 follow by 10 days without treatment * Dexamethasone 40 mg/v.o. days 1-4 (Cycles of 21 days) EXTENSION TREATMENT(Cycles 9-12) * Bortezomib 1,3 mg/m2 i.v. days 1, 8, 15 and 22 * Dexamethasone 40 mg/d v.o. days 1-4 (Every 6 weeks) | Drug | – |
Primary outcome
Efficacy
Time frame: 2 years
Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone treatment
3 secondary outcomes
Progression-free survival
Time frame: 2 years
Overall survival
Time frame: 4 years
Safety
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- web Haematology Spanish AssociationLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 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 velcade in people with Multiple Myeloma, run by PETHEMA Foundation at 11 sites in Spain.
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 17 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: finished, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy (time frame: 2 years). 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 17 Sep 2015.