Multiple MyelomaPhase 1/2NCT01002703
Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1/2 study testing Lenalidomide, Bendamustine, Prednisone in people with Multiple Myeloma, run by University of Leipzig at 1 site in Germany.
Trial summary
Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone. 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?
- Lenalidomide, Bendamustine, Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Oct 2014
- Phase
- Phase 1/2
- 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
- Understand and voluntarily sign an informed consent form.
- Age 18 years at the time of signing the informed consent form.
- Life expectancy of at least 3 months
- Able to adhere to the study visit schedule and other protocol requirements
- Relapsed or refractory MM (only first or second relapse) in stage II or III after autologous SCT or conventional chemotherapy (histologically or cytologically proven/ Salmon and Durie criteria) with detectable myeloma protein in blood or urine
- All previous cancer therapies, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, without corticosteroids therapy.
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- ECOG performance status of £ 2 at study entry (see Appendix 01).
- Laboratory test results within ranges
- Females of childbearing potential must agree to contraception or abstinence
- Disease free of prior malignancies for ³ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Patients with contraindications (exclusion criteria) for treatment with lenalidomide, bendamustine and prednisone.
- Uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ Lown 3).
- Use of any other experimental drug or therapy within 28 days of baseline.
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- Known hypersensitivity to thalidomide or purine analogues
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior use of lenalidomide or bendamustine in the last six months
- Concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.
- Known positive for HIV or infectious hepatitis, type A, B or C.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Leipzig
Leipzig, 04103
Dietger Niederwieser, +4934197 ext. 13050, dietger@medizin.uni-leipzig.de
Wolfram Pönisch
About this study
Official title: Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma After Autologous Stem Cell Transplantation or Conventional Chemotherapy OSHO #077
Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.
- Conditions
- Multiple Myeloma
- Being tested
- Lenalidomide, Bendamustine, Prednisone
- Keywords
- Lenalidomide, Bendamustine, Multiple Myeloma, Myeloma, Revlimid, Phase I/II, refractory Myeloma, relapsed Myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide, Bendamustine, PrednisoneDrug
During the study the first cohort of subjects receive a starting dose of lenalidomide 10mg/d d1-21, bendamustine 60mg/m²/d d1-2 and prednisone 100mg/d d1-4. Escalation steps will include 15, 20 and 25 mg of lenalidomide and 75mg/m² for bendamustine.
| Study group | Role | What they receive |
|---|---|---|
| RBP | Experimental | Lenalidomide and Bendamustine and Prednisone Receives: Drug: Lenalidomide, Bendamustine, Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerable dose (MTD) of lenalidomide in combination with bendamustine and prednisone (RBP) in refractory and relapsed MM stage I/III
Measured: 2 month
Secondary outcomes (1)
To determine the safety of lenalidomide, bendamustine and prednisone at MTD
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2012 (estimated)
- Study completionOct 2014 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Mundipharma Pte Ltd., Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002703
- Sponsor's protocol ID
- RBP-01/08
- Other IDs
- OSHO77
- Status last verified
- Oct 2009
- First submitted
- 23 Oct 2009
- Last updated
- 12 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma After Autologous Stem Cell Transplantation or Conventional Chemotherapy OSHO #077
- ClinicalTrials.gov ID
- NCT01002703
- Acronym / sponsor ID
- RBP-01/08
- Conditions
- Multiple Myeloma
- Keywords
- Lenalidomide, Bendamustine, Multiple Myeloma, Myeloma, Revlimid, Phase I/II, refractory Myeloma, relapsed Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Celgene Corporation, Mundipharma Pte Ltd., Amgen
- Study start
- Sep 2009
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 27 Oct 2009 (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.
Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RBP | Experimental | Drug: Lenalidomide, Bendamustine, PrednisoneLenalidomide and Bendamustine and Prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Understand and voluntarily sign an informed consent form.
- Age 18 years at the time of signing the informed consent form.
- Life expectancy of at least 3 months
- Able to adhere to the study visit schedule and other protocol requirements
- Relapsed or refractory MM (only first or second relapse) in stage II or III after autologous SCT or conventional chemotherapy (histologically or cytologically proven/ Salmon and Durie criteria) with detectable myeloma protein in blood or urine
Key exclusion criteria (11 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Patients with contraindications (exclusion criteria) for treatment with lenalidomide, bendamustine and prednisone.
- Uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ Lown 3).
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 |
|---|---|---|
| Lenalidomide, Bendamustine, PrednisoneDuring the study the first cohort of subjects receive a starting dose of lenalidomide 10mg/d d1-21, bendamustine 60mg/m²/d d1-2 and prednisone 100mg/d d1-4. Escalation steps will include 15, 20 and 25 mg of lenalidomide and 75mg/m² for bendamustine. | Drug | RBP |
Primary outcome
To determine the maximum tolerable dose (MTD) of lenalidomide in combination with bendamustine and prednisone (RBP) in refractory and relapsed MM stage I/III
Time frame: 2 month
1 secondary outcome
To determine the safety of lenalidomide, bendamustine and prednisone at MTD
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2011.
- Related InfoLink 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenalidomide, Bendamustine, Prednisone in people with Multiple Myeloma, run by University of Leipzig at 1 site in Germany.
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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Aug 2011. 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 Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dietger Niederwieser (+4934197 ext. 13050, dietger@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the maximum tolerable dose (MTD) of lenalidomide in combination with bendamustine and prednisone (RBP) in refractory and relapsed MM stage I/III (time frame: 2 month). 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 12 Aug 2011.