Multiple MyelomaPhase 1/2NCT00778752
Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma
A Phase 1/2 study testing Revlimid (Lenalidomide) in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
Trial summary
This study is a Phase I (non-randomized) study evaluating three dose-levels of Lenalidomide in patients after allogeneic stem cell transplantation, accomplished in two institutions (University Medical Center Hamburg-Eppendorf/ University Medical Center Heidelberg). 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?
- Revlimid (Lenalidomide)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2009to Dec 2013
- 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 informed consent form
- Age > 18 years at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Multiple myeloma patients who received allogeneic stem cell transplantation (100 to 180 days ago)
- No active acute GvHD (grade II - IV)
- No active infectious complications
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- ECOG performance status of < 2 at study entry
- Laboratory test results within these ranges:
- Absolute WBC count > 3.0 x 10^9/l
- Platelet count > 80 x 10^9/l
- Serum creatinine < 1.5 mg/dl
- Total bilirubin < 1,5 mg/dl
- AST (SGOT) and ALT (SGPT) < 3 x ULN
- Females of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse for at least 28 days before starting study drug, while participating in the study and at least 28 days after discontinuation from the study.
- male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days after discontinuation of study drug
- disease free of prior malignancies for > 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" 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
- use of any other experimental drug or therapy within 28 days of baseline
- known hypersensitivity to thalidomide
- concurrent use of other anti-cancer agents or treatments
- known positive for HIV of infectious hepatitis, type A, B, or C
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Universitätsklinikum Heidelberg
Heidelberg, 69120
About this study
Official title: Dose-finding Study of Lenalidomide as Maintenance Therapy in Multiple Myeloma After Allogeneic Stem Cell Transplantation
This study is a Phase I (non-randomized) study evaluating three dose-levels of Lenalidomide in patients after allogeneic stem cell transplantation, accomplished in two institutions (University Medical Center Hamburg-Eppendorf/ University Medical Center Heidelberg).
- Conditions
- Multiple Myeloma
- Being tested
- Revlimid (Lenalidomide)
- Keywords
- Multiple Myeloma, Stem Cell Transplantation, Revlimid, Lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revlimid (Lenalidomide)Drug
3 pat. will be enrolled on dose level 0. If no DLTs are observed during cycles 1+2 dose will be escalated to the next higher level in the 3 patients. If 1 of 3 pat. experiences DLT at the current dose, then up to 3 more pat. will be accrued at the same level. If none of these 3 additional pat. experience DLT dose will be escalated in subsequent patients. If 1 of these 3 patients experiences DLT, the next lower level will be declared to be MTD and the study will be filled up with patients at this dose level up to 25 pat. overall.
If 2 or more of 3 pat. or 3 or more of 6 pat. in the same cohort encounter DLT, the MTD has been exceeded and the previous lower dose level will be declared as MTD and the study will be filled up with patients at this level up to 25 pat. overall.
If DLT is observed in level 0, the next dose level will be -1 for the following cohort of 3 patients. If level 2 is well tolerated without DLT, this level will be claimed as recommended dose for further trials.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Lenalidomide-treatment starts between 100 and 180 days after allogeneic stem cell transplantation. Three dose-levels will be investigated.
* Dose-level -1: 2.5 mg/d if 2.5mg capsules are available, day 1-21, otherwise 5 mg every other day, day 1-21
* Dose-level 0: 5 mg/d, day 1-21
* Dose-level 1: 10 mg/d, day 1-21
* Dose-level 2: 15 mg/d, day 1-21 Receives: Drug: Revlimid (Lenalidomide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma
Measured: 2 years post-transplantation
Secondary outcomes (3)
Determination of remission status after lenalidomide treatment
Measured: 2 years post-transplantation
Effect on T-cell/ NK-cell recovery
Measured: 1 year post-transplantation
Incidence of infectious complications and GvHD
Measured: 1 year post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startApr 2009
- Primary completionMar 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolaus Kroeger, Prof. Dr., Principal investigator, University Medical Center Hamburg-Eppendorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778752
- Sponsor's protocol ID
- Revlimid as maintenance in MM
- Status last verified
- May 2015
- First submitted
- 22 Oct 2008
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolschke C, Stubig T, Hegenbart U, Schonland S, Heinzelmann M, Hildebrandt Y, Ayuk F, Atanackovic D, Dreger P, Zander A, Kroger N. Postallograft lenalidomide induces strong NK cell-mediated antimyeloma activity and risk for T cell-mediated GvHD: Results from a phase I/II dose-finding study. Exp Hematol. 2013 Feb;41(2):134-142.e3. doi: 10.1016/j.exphem.2012.10.004. Epub 2012 Oct 17.
PubMed 23085463
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-finding Study of Lenalidomide as Maintenance Therapy in Multiple Myeloma After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00778752
- Acronym / sponsor ID
- Revlimid as maintenance in MM
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Stem Cell Transplantation, Revlimid, Lenalidomide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Oct 2008 (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.
This study is a Phase I (non-randomized) study evaluating three dose-levels of Lenalidomide in patients after allogeneic stem cell transplantation, accomplished in two institutions (University Medical Center Hamburg-Eppendorf/ University Medical Center Heidelberg).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Revlimid (Lenalidomide)Lenalidomide-treatment starts between 100 and 180 days after allogeneic stem cell transplantation. Three dose-levels will be investigated. * Dose-level -1: 2.5 mg/d if 2.5mg capsules are available, day 1-21, otherwise 5 mg every other day, day 1-21 * Dose-level 0: 5 mg/d, day 1-21 * Dose-level 1: 10 mg/d, day 1-21 * Dose-level 2: 15 mg/d, day 1-21 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Understand and voluntarily sign informed consent form
- Age > 18 years at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Multiple myeloma patients who received allogeneic stem cell transplantation (100 to 180 days ago)
- No active acute GvHD (grade II - IV)
Key exclusion criteria (6 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
- use of any other experimental drug or therapy within 28 days of baseline
- known hypersensitivity to thalidomide
- concurrent use of other anti-cancer agents or treatments
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 |
|---|---|---|
| Revlimid (Lenalidomide)3 pat. will be enrolled on dose level 0. If no DLTs are observed during cycles 1+2 dose will be escalated to the next higher level in the 3 patients. If 1 of 3 pat. experiences DLT at the current dose, then up to 3 more pat. will be accrued at the same level. If none of these 3 additional pat. experience DLT dose will be escalated in subsequent patients. If 1 of these 3 patients experiences DLT, the next lower level will be declared to be MTD and the study will be filled up with patients at this dose level up to 25 pat. overall. If 2 or more of 3 pat. or 3 or more of 6 pat. in the same cohort encounter DLT, the MTD has been exceeded and the previous lower dose level will be declared as MTD and the study will be filled up with patients at this level up to 25 pat. overall. If DLT is observed in level 0, the next dose level will be -1 for the following cohort of 3 patients. If level 2 is well tolerated without DLT, this level will be claimed as recommended dose for further trials. | Drug | A |
Primary outcome
Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma
Time frame: 2 years post-transplantation
3 secondary outcomes
Determination of remission status after lenalidomide treatment
Time frame: 2 years post-transplantation
Effect on T-cell/ NK-cell recovery
Time frame: 1 year post-transplantation
Incidence of infectious complications and GvHD
Time frame: 1 year post-transplantation
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 13 May 2015.
- Derived from this study: PubMed 23085463Wolschke C, Stubig T, Hegenbart U, Schonland S, Heinzelmann M, Hildebrandt Y, Ayuk F, Atanackovic D, Dreger P, Zander A, Kroger N. Postallograft lenalidomide induces strong NK cell-mediated antimyeloma activity and risk for T cell-mediated GvHD: Results from a phase I/II dose-finding study. Exp Hematol. 2013 Feb;41(2):134-142.e3. doi: 10.1016/j.exphem.2012.10.004. Epub 2012 Oct 17.
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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.
Nicolaus Kroeger, Prof. Dr. principal investigator
University Medical Center Hamburg-Eppendorf, Germany
2 sites 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 Revlimid (Lenalidomide) in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites 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 16 inclusion and 6 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 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma (time frame: 2 years post-transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00778752, which also lists 1 linked publication.
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 13 May 2015.