Multiple MyelomaPhase 2NCT00925821
Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
A Phase 2 study testing allogeneic stem cell transplant versus second autologous transplantation and RAD in people with Multiple Myeloma, run by Wuerzburg University Hospital at 12 sites in Germany.
Trial summary
Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is permitted. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- allogeneic stem cell transplant versus second autologous transplantation and RAD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 12 sitesGermany
- Study dates
- Jun 2009to not given
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Newly diagnosed multiple myeloma
- Maximum of one prior systemic therapy (2 cycles)
- Presence of CRAB criteria
- Measurable disease parameters
- Left ventricular ejection fraction at least 55%
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- DLCO of at least 60%
- Adequate bone marrow function
- Use of adequate contraception for female subjects with childbearing potential and all male subjects
- Eligible for autologous and allogeneic stem cell transplantation
- Bone marrow baseline sample evaluable for interphase cytogenetics
Who cannot join
- Any serious medical conditions preventing the subject from written informed consent
- Progressive disease (PD) to any initial treatment
- Pregnant or lactating 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
- Use of any other experimental drug or therapy within 28 days of baseline
- Preexisting neuropathy of ≥ grade 2 severity
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- Known hypersensitivity to thalidomide
- Any prior use of lenalidomide
- Positive for HIV or infectious hepatitis, type A, B or C after serologic testing
- Serum creatinine despite induction therapy ≥ 2.0 mg/dL
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Charité University Hospital - Virchow Klinikum
Berlin
Dresden University Hospital
Dresden, 01307
Erlangen University Hospital
Erlangen, 91054
Freiburg University Hospital
Freiburg im Breisgau, 79106
Jena University Hospital
Jena
Kiel University Hospital
Kiel, 24105
Munich Grosshadern University Hospital
Munich, 81377
University Hospital of Munich Technical University
Munich, 81675
Klinikum Nuremberg
Nuremberg, 90419
Regensburg University Hospital
Regensburg, 93053
Rostock University Hospital
Rostock, 18057
Ulm University Hospital
Ulm, 89081
About this study
Official title: Lenalidomide (Revlimid®), Adriamycin and Dexamethasone (RAD)as an Induction Therapy in Newly Diagnosed Multiple Myeloma Followed by a Risk-Defined Transplant Strategy and Lenalidomide Maintenance - A Multicenter Phase II Trial by Deutsche Studiengruppe Multiples Myeloma (DSMM XII)
Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is permitted. After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. If at least a minimal response is achieved to RAD, they will undergo chemomobilization (cyclophosphamide, etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan chemotherapy followed by a first stem cell transplant. If any of the high-risk features (such as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated LDH, Ig A isotype) were present at diagnosis, patients will be allocated to a consolidative allogeneic transplant following dose-reduced conditioning. If no appropriate donor is available, the patient does not consent or lacks of high-risk features a second autograft following high-dose melphalan will be delivered. All patients will proceed to lenalidomide maintenance (one year) following hematopoietic reconstitution.
- Conditions
- Multiple Myeloma
- Being tested
- allogeneic stem cell transplant versus second autologous transplantation, RAD
- Keywords
- Allogeneic stem cell transplantation, Lenalidomide, IMiD
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic stem cell transplant versus second autologous transplantationProcedure or surgery
Transplantation of stem cells from a MRD or MUD, respectively after dose-reduced conditioning versus autologous stem cell graft after preparation with melphalan 200 mg/m²
RADDrug
After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic stem cell transplant | Experimental | Second scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine Receives: Procedure: allogeneic stem cell transplant versus second autologous transplantation; Drug: RAD |
| High-dose melphalan chemotherapy | Active comparator | Second high-dose melphalan therapy followed by transplantation of peripheral blood stem cells Receives: Procedure: allogeneic stem cell transplant versus second autologous transplantation; Drug: RAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate to RAD induction and transplant (stringent CR, CR, very good PR)
Measured: 9 months from start of treatment
Secondary outcomes (2)
Progression-free survival (PFS)
Measured: 9 months from start of treatment
Incidence and relationship of severe adverse events
Measured: 1 year from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2009
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
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ClinAssess GmbH, Celgene Corporation, Amgen, medac GmbH
- Responsible party
- Sponsor
- Investigators
- Ralf C Bargou, MD, Principal investigator, Wuerzburg University Hospital, Dept. of Internal Medicine II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925821
- Sponsor's protocol ID
- DSMM XII
- Status last verified
- Jun 2012
- First submitted
- 16 Jun 2009
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenalidomide (Revlimid®), Adriamycin and Dexamethasone (RAD)as an Induction Therapy in Newly Diagnosed Multiple Myeloma Followed by a Risk-Defined Transplant Strategy and Lenalidomide Maintenance - A Multicenter Phase II Trial by Deutsche Studiengruppe Multiples Myeloma (DSMM XII)
- ClinicalTrials.gov ID
- NCT00925821
- Acronym / sponsor ID
- DSMM XII
- Conditions
- Multiple Myeloma
- Keywords
- Allogeneic stem cell transplantation, Lenalidomide, IMiD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- ClinAssess GmbH, Celgene Corporation, Amgen, medac GmbH
- Study start
- Jun 2009
- First posted
- 22 Jun 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.
Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is permitted. After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. If at least a minimal response is achieved to RAD, they will undergo chemomobilization (cyclophosphamide, etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan chemotherapy followed by a first stem cell transplant. If any of the high-risk features (such as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated LDH, Ig A isotype) were present at diagnosis, patients will be allocated to a consolidative allogeneic transplant following dose-reduced conditioning. If no appropriate donor is available, the patient does not consent or lacks of high-risk features a second autograft following high-dose melphalan will be delivered. All patients will proceed to lenalidomide maintenance (one year) following hematopoietic reconstitution.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic stem cell transplant | Experimental | Procedure: allogeneic stem cell transplant versus second autologous transplantation, Drug: RADSecond scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine |
| High-dose melphalan chemotherapy | Active comparator | Procedure: allogeneic stem cell transplant versus second autologous transplantation, Drug: RADSecond high-dose melphalan therapy followed by transplantation of peripheral blood stem cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent
- Newly diagnosed multiple myeloma
- Maximum of one prior systemic therapy (2 cycles)
- Presence of CRAB criteria
- Measurable disease parameters
Key exclusion criteria (10 listed)
- Any serious medical conditions preventing the subject from written informed consent
- Progressive disease (PD) to any initial treatment
- Pregnant or lactating 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
- Use of any other experimental drug or therapy within 28 days of baseline
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 |
|---|---|---|
| allogeneic stem cell transplant versus second autologous transplantationTransplantation of stem cells from a MRD or MUD, respectively after dose-reduced conditioning versus autologous stem cell graft after preparation with melphalan 200 mg/m² | Procedure or surgery | Allogeneic stem cell transplant, High-dose melphalan chemotherapy |
| RADAfter enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. | Drug | Allogeneic stem cell transplant, High-dose melphalan chemotherapy |
Primary outcome
Response rate to RAD induction and transplant (stringent CR, CR, very good PR)
Time frame: 9 months from start of treatment
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 9 months from start of treatment
Incidence and relationship of severe adverse events
Time frame: 1 year from start of treatment
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 28 Jun 2012.
- Website of the German Lymphoma Competence NetLink 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.
Ralf C Bargou, MD principal investigator
Wuerzburg University Hospital, Dept. of Internal Medicine II
12 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 allogeneic stem cell transplant versus second autologous transplantation and RAD in people with Multiple Myeloma, run by Wuerzburg University Hospital at 12 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 11 inclusion and 10 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 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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?
Response rate to RAD induction and transplant (stringent CR, CR, very good PR) (time frame: 9 months from start of treatment). 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 28 Jun 2012.