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Previously Untreated Symptomatic Multiple MyelomaPhase 3NCT01685814

Lenalidomide, Adriamycin, Dexamethasone (RAD) Versus Lenalidomide, Bortezomib, Dexamethasone (VRD) for Induction in Newly Diagnosed Multiple Myeloma Followed by Response-adapted Consolidation and Lenalidomide Maintenance

A Phase 3 study testing Lenalidomide, Bortezomib, autologous stem cell transplant and allogeneic stem cell transplant in people with Previously Untreated Symptomatic Multiple Myeloma, run by Wuerzburg University Hospital at 32 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators propose this study utilizing Lenalidomide, Adriamycin, Dexamethasone (RAD) as comparator arm for Lenalidomide, Bortezomib, Dexamethasone (VRD) with the latter being considered a novel "standard" as an induction protocol, since response in general occurs early after starting treatment we decided to… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Lenalidomide, Bortezomib, autologous stem cell transplant and allogeneic stem cell transplant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
32 sitesGermany
Study dates
May 2012to Dec 2023
Phase
Phase 3
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

  • Understand and voluntarily sign an informed consent form
  • Patients willing and able to undergo autologous and allogeneic transplantation
  • no previous systemic therapy for the treatment of multiple myeloma (dexamethasone at a cumulative dose of 320 mg; plasmapheresis/dialysis without concomitant chemotherapy, local irradiation of bone lesions; and surgical intervention is accepted as pretreatment)
  • Newly diagnosed multiple myeloma according to common diagnostic criteria including presence of CRAB and measurable disease parameters
  • Cardiac ejection fraction (LVEF) of at least 50%
  • Corrected DLCO of at least 50% ; alternatively pO2 [art.] of at least 70mmHg
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  • Karnofsky performance status of greater or equal to 50%
  • adequate bone marrow function
  • adequate serum chemistry values
  • Use of adequate contraception for female subjects with childbearing potential and male subjects
  • Bone marrow sample available for analysis of molecular cytogenetics
  • Able to administer low molecular-weight heparin as a prophylactic anticoagulation therapy for the first three months(applicable for subjects randomized to RAD) and able to administer ASS 100 mg/d (applicable for subjects randomized to VRD)

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 lactating females
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk
  • History of myocardial infarction; NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias; concomitant pericarditis or peri-/myocarditis
  • Use of any other experimental drug or therapy within 28 days of baseline
  • Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment
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  • Known intolerance of boron
  • Hypersensitivity to acyclovir or similar anti-viral drug
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer
  • HIV positive, active hepatitis B, C or D viral infection, known CMV reactivation/active infection, EBV reactivation/active infection or treponema pallidum infection
  • Uncontrolled diabetes mellitus
  • Non-secretory MM
  • Clinically relevant active infection or serious co-morbid medical conditions

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Germany32 sites

  • Universitätsklinikum Aachen, Med. Klinik IV, Hämatologie u. Onkologie

    Aachen, 52074

  • Schön Klinik Starnberger See, Hämatologie und Onkologie

    Berg, 82335

  • Charité Campus Virchow-Klinikum, Hämatologie, Onkologie u. Tumorimmunologie

    Berlin, 13353

  • Klinikum Bremen-Mitte gGmbH, Klinik für Innere Medizin I

    Bremen, 28177

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik I

    Dresden, 01307

  • Universitätsklinikum Erlangen, Medizinische Klinik 5

    Erlangen, 91054

  • Malteser Krankenhaus St. Franziskus-Hospital, medizinische Klinik I

    Flensburg, 24939

  • Klinikum Frankfurt (Oder) GmbH Medizinische Klinik I

    Frankfurt (Oder), 15236

  • Klinikum der Johann Woflgang Goethe Universität, Frankfurt am Mai

    Frankfurt am Main, 60596

  • Universitätsklinikum Freiburg, Abteilung für Innere Medizin I

    Freiburg im Breisgau, 79106

  • Universitätmedizin Greifswald, Klinik und Poliklinik für Innere Medizin C

    Greifswald, 17475

  • St. Marien-Hospital gem. GmbHKna

    Hamm, 59071

  • Universitätsklinikum des Saarlandes Innere Medizin I

    Homburg/Saar, 66421

  • Klinikum der Friedrich-Schiller-Universität Jena, Klinikum für Innrere Medizin II

    Jena, 07747

  • Städtisches Klinikum Karlsruhe Medizinische Klinik III, Abt. Hämatologie u. Onkologie

    Karlsruhe, 76133

  • Universitätsklinikum Schleswig-Holstein Campus Kiel, II. Med. Poliklinik

    Kiel, 24105

  • Universitätsklinikum Schleswig-Holstein, Medizinische Klinik und Poliklinik II im städtischen Krankenhaus Kiel

    Kiel, 24116

  • Stiftungsklinikum Mittelrhein GmbH, Klinik für Innere Medizin

    Koblenz, 56068

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik I

    Lübeck, 23538

  • Universitätsmedizin Mannheim medizinische Klinik III

    Mannheim, 68167

  • Klinikum Schwabing

    München, 80804

  • Klinikum der Universität München-Großhadern

    München, 81366

  • III. Med. Klinik und Poliklinik, Klinikum rechts der Isar der TU München

    München, 81675

  • Universitätsklinikum Münster, Medizinische Klinik u. Poliklinik A

    Münster, 48149

  • Klinikum Nürnberg Nord, 5. Medizinische LKinik, Onkologie/Hämatologie

    Nuremberg, 90419

  • Klinikum Oldenburg GmbH, Klinik für Innere Medizin II

    Oldenburg, 26133

  • Uniklinikum Regensburg, Abteilung für Hämatologie und internistische Onkologie

    Regensburg, 93053

  • Robert-Bosch-Krankenhaus, Abt. Hämatologie, Onkologie u. Palliativmedizin

    Stuttgart, 70376

  • Universitätsklinikum Ulm,Klinik für Innere Medizin III

    Ulm, 89081

  • Schwarzwald-Baar Klinkum Villingen-Schwennigen GmbH

    Villingen-Schwenningen, 78048

  • Dr. Horst Schmidt Kliniken, Klinik Innere Medizin III

    Wiesbaden, 65199

  • Universitätsklinikum Wuerzburg, Medizinische Klinik II

    Würzburg, 97080

Other trials in Germany

About this study

Official title: Lenalidomide, Adriamycin, Dexamethasone (RAD) Versus Lenalidomide, Bortezomib, Dexamethasone (VRD) for Induction in Newly Diagnosed Multiple Myeloma Followed by Response-adapted Consolidation and Lenalidomide Maintenance - A Randomized Multicenter Phase III Trial by Deutsche Studiengruppe Multiples Myelom (DSMM XIV

The investigators propose this study utilizing Lenalidomide, Adriamycin, Dexamethasone (RAD) as comparator arm for Lenalidomide, Bortezomib, Dexamethasone (VRD) with the latter being considered a novel "standard" as an induction protocol, since response in general occurs early after starting treatment we decided to choose three cycles of either induction regimen.

Together with the "novel compounds", tandem high-dose melphalan is still the standard of care; it seems desirable to re-address the question of the number of transplant (single vs. double high-dose melphalan) procedures required in the context of triplet-induction protocols utilizing at least one of the novel compounds.

Read more

Thus, the question to be asked in the current protocol is whether immediate lenalidomide maintenance (i.e. following one cycle of high-dose therapy) as an investigational agent will result in identical progression free survival (PFS) when compared to tandem high-dose melphalan with deferred maintenance therapy.

Despite induction with novel compounds, approximately 25 - 40% of patients will be in less than very good partial response. Very recently, achievement of less than VGPR was confirmed to negatively impact on both PFS as well as overall survival (OS). Therefore, allogeneic stem cell transplantation is considered the standard of care in patients with suboptimal response to a first autograft.

In the current protocol, the standard for favourable responders (tandem-autologous transplant) is combined with 3 years of lenalidomide maintenance. This approach will be investigated for patients with less than VGPR following a first autotransplant and compared to the current standard of intensification in poor responders (allogeneic transplantation).

Being tested
Lenalidomide, Bortezomib, autologous stem cell transplant, allogeneic stem cell transplant
Keywords
multiple myeloma, autologous stem cell transplant, allogeneic stem cell transplant, lenalidomide, bortezomib
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lenalidomide, BortezomibDrug

    Induction: two versus one novel drug maintenance: lenalidomide as a maintenance therapy

  • autologous stem cell transplantBiological

  • allogeneic stem cell transplantBiological

Study groups in NCT01685814
Study groupRoleWhat they receive
single stem cell transplant, 3-year lenalidomide maintenanceActive comparatorArm A
Receives: Drug: Lenalidomide, Bortezomib; Biological: autologous stem cell transplant
tandem autologous transplant, lenalidomide maintenanceExperimentalArm B
Receives: Drug: Lenalidomide, Bortezomib; Biological: autologous stem cell transplant
allogeneic stem cell transplant, lenalidomide maintenanceActive comparatorArm C
Receives: Drug: Lenalidomide, Bortezomib; Biological: autologous stem cell transplant; Biological: allogeneic stem cell transplant
tandem autologous transplantExperimentalArm D
Receives: Drug: Lenalidomide, Bortezomib; Biological: autologous stem cell transplant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy endpoint for the induction phase is the rate of patients with CR at first restaging

    Measured: within 8 days after end of last induction cycle ((Day 92(RAD); Day 71(VRD))

  2. In the consolidation phase the primary efficacy endpoint for comparison II (response <VGPR after first ASCT) is the PFS rate

    Measured: 3 years after the first ASCT, calculated from day 1 of ASCT.

Secondary outcomes (5)

  1. ORR following 3 cycles of induction treatment (VRD vs RAD)

    Measured: within 8 days after end of last induction cycle

  2. CR and ORR at the end of the whole treatment programme

    Measured: at the end of the whole treatment programme (approx. 8 years)

  3. Overall survival (OS)

    Measured: 8 years from study entry

  4. Incidence, severity and relationship of SAEs

    Measured: 30 days post last dosing of study drug

  5. Numbers of hospital stays and hospitalization days

    Measured: within two years from second restaging

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionSep 2016
  4. Study completionDec 2023 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
406 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01685814
Sponsor's protocol ID
DSMM XIV
Other IDs
2009-016616-21, 2009
Status last verified
Apr 2023
First submitted
27 Jun 2012
Last updated
27 Apr 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide, Bortezomib, autologous stem cell transplant and allogeneic stem cell transplant in people with Previously Untreated Symptomatic Multiple Myeloma, run by Wuerzburg University Hospital at 32 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 12 inclusion and 13 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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

The primary efficacy endpoint for the induction phase is the rate of patients with CR at first restaging (time frame: within 8 days after end of last induction cycle ((Day 92(RAD); Day 71(VRD))). The study lists 2 primary outcomes in all. 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 NCT01685814.

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 27 Apr 2023.

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