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Multiple MyelomaPhase 3DSM XIIINCT01090089

Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma

A Phase 3 study testing Lenalidomide, Dexamethasone and Lenalidomide, Dexamethasone, PBSCT in people with Multiple Myeloma, run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 31 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study for elderly myeloma patients lenalidomide plus low-dose dexamethasone until progression is being compared with age-adjusted tandem high-dose melphalan 140 mg/m² augmented by induction with 3 cycles of lenalidomide plus low-dose dexamethasone before transplantation and lenalidomide maintenance after… Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Lenalidomide, Dexamethasone and Lenalidomide, Dexamethasone, PBSCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
348 participants
Where
31 sitesGermany
Study dates
1 Mar 2010to 31 Jan 2020
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 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Understand and voluntarily sign an informed consent form. 2. Age 60-75 years at the time of signing the informed consent form. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Symptomatic MM requiring therapy. 5. Measurable monoclonal protein in serum and/or urine 6. Monoclonal plasma cells in the bone marrow >/= 10% and/or biopsy-proven plasmacytoma 7. Myeloma-related organ dysfunction, at least one of [C] Calcium elevation in the serum (> 11.5 mg/dL or > 2.65 mmol/l) [R] Renal insufficiency (creatinine > 173 μmol/l or > 2 mg/dL) [A] Anemia (Hb < 10 g/dL or 2 g/dL < normal) [B] Bone lesions or general osteoporosis 8. ECOG PS of </= 2 ... 9. Laboratory test results within these ranges within 1 week prior to randomization:
  • ANC >/= 1.0 x 109/L.
  • Platelet count >/= 75 x 109/L or in case of bone marrow infiltration with myeloma cells >/= 30 x 109/L.
  • Total bilirubin </= 2 mg/dL.
  • AST (SGOT) and ALT (SGPT) </= 3 x ULN. 8. Female subjects of childbearing potential must: o Understand the study drug is expected to have a teratogenic risk
  • o Agree to use, ..., effective contraception without interruption,...
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  • o Understand that even if she has amenorrhea, she must follow all the advice on effective contraception.
  • o She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
  • o Agree to have a medically supervised pregnancy test ...
  • Male subjects must
  • o Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study drug therapy ...
  • Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
  • All subjects must
  • Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
  • Agree not to share study drug with another person and to return all unused study drug to the investigator.
  • 9. 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.
  • 10. Able to receive antithrombotic prophylaxis (...). 11. Life-expectancy > 3 months.

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF.
  • Pregnant or lactating females
  • Any condition, incl. 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.
  • Patient currently is enrolled in another clinical research study or has been enrolled ...within 4 weeks before randomization and/or is receiving an investigational agent for any reason ...
  • Known hypersensitivity to thalidomide, dexamethasone, or melphalan.
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
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  • Any prior use of lenalidomide.
  • Concurrent use of other anti-cancer agents or treatments.
  • Known positive for HIV or active infectious hepatitis, type A, B or C or treponema pallidum
  • Prior treatment with dexamethasone discontinued because of ≥ grade 3 dexamethasone-related toxicity.
  • Any prior chemotherapy with the exception of a short course of dexamethasone more than 4 weeks before randomization.
  • Immunotherapy or antibody therapy within 8 weeks before randomization.
  • Major surgery within 4 weeks before randomization.
  • Renal failure requiring dialysis.
  • Myocardial infarction within 6 months before randomization, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Severe pulmonary disease (diffusion capacity < 60% of normal).
  • Treatment for cancer other than MM within 5 years before randomization, with the exception of basal cell carcinoma or cervical cancer in situ.
  • Cardiac amyloidosis.
  • Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.
  • Any systemic infection requiring treatment.
  • Unability or unwillingness of the patient to receive antithrombotic prophylaxis.
  • -

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Germany31 sites

  • Universitätsklinikum Aachen

    Aachen, 52074

  • Agirov Klinik

    Berg, 82335

  • HELIOS Klinikum Berlin-Buch

    Berlin, 13125

  • Evangelisches Krankenhaus Bielefeld

    Bielefeld, 33611

  • Klinikum Bremen-Mitte

    Bremen, 28177

  • Universitätsklinik Erlangen

    Erlangen, 91054

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Göttingen

    Göttingen, 37075

  • Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald -Anstalt öffentlichen Rechts-

    Greifswald, 17475

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • Stiftungsklinikum Mittelrhein gGmbH

    Koblenz, 56068

  • Klinikum Landshut gemeinnützige GmbH

    Landshut, 84034

  • Hämato-Onkologische Schwerpunktpraxis

    München, 80331

  • Onkologische Praxis Elisenhof

    München, 80335

  • Klinikum München Harlaching

    München, 81545

  • Klinikum rechts der Isar

    München, 81675

  • Universitätsklinikum Münster

    Münster, North Rhein Westfallen, 48149

  • Stauferklinikum Schwäbisch Gmünd

    Mutlangen, 73557

  • Klinikum Nord

    Nuremberg, 90419

  • Klinikum Oldenburg

    Oldenburg, 26133

  • Klinikum Ernst von Bergmann gGmbH

    Potsdam, 14467

  • Gemeinschaftspraxis für Innere Medizin, Hämatologie und Onkologie

    Ravensburg, 88214

  • Klinikum der Universität Regensburg

    Regensburg, 93053

  • Diakonie-Klinikum Stuttgart-Diakonissenkrankenhaus und Paulinenhilfe gGmbH

    Stuttgart, 70176

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Klinikum Traunstein

    Traunstein, 83278

  • Universitätsklinikum Ulm

    Ulm, 89081

  • HSK Dr. Horst-Schmidt-Kliniken gmbh

    Wiesbaden, 65199

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

About this study

Official title: The Combination of Lenalidomide and Dexamethasone With or Without Intensification by High-dose Melphalan in the Treatment of Multiple Myeloma

In this study for elderly myeloma patients lenalidomide plus low-dose dexamethasone until progression is being compared with age-adjusted tandem high-dose melphalan 140 mg/m² augmented by induction with 3 cycles of lenalidomide plus low-dose dexamethasone before transplantation and lenalidomide maintenance after transplantation.

Being tested
Lenalidomide, Dexamethasone, Lenalidomide, Dexamethasone, PBSCT
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, DexamethasoneDrug

    Also called Revlimid

    Rd until progression or max. 5 years (Rd = lenalidomide 25 mg d1-21/28d + dexamethasone 40 mg po d1, d8, d15, d22/28d)

  • Lenalidomide, Dexamethasone, PBSCTDrug

    Also called Revlimid

    Induction with 3 cycles Rd, tandem high dose melphalan (140 mg/m²) with autologous peripheral blood stem cell transplantation (PBSCT) followed by lenalidomide maintenance (10 mg/day) until progression or max. 5 years

Study groups in NCT01090089
Study groupRoleWhat they receive
Lenalidomid, PBSCTExperimentalA1 Rd until progression or max. 5 years (Rd = lenalidomide 25 mg d1-21/28d + dexamethasone 40 mg po d1, d8, d15, d22/28d)
Receives: Drug: Lenalidomide, Dexamethasone, PBSCT
LenalidomidActive comparatorA2 Induction with 3 cycles Rd, tandem high dose melphalan (140 mg/m²) with autologous peripheral blood stem cell transplantation (PBSCT) followed by lenalidomide maintenance (10 mg/day) until progression or max. 5 years
Receives: Drug: Lenalidomide, Dexamethasone

What is being measured

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

  1. Progression-free survival (PFS)

    To compare the efficacy of both treatment regimens with regard to progression-free survival.

    Measured: 5 yrs

Secondary outcomes (2)

  1. Overall survival (OS)

    To assess the safety and overall survival of both treatment regimens.

    Measured: 5 yrs

  2. • Response (complete response [CR], stringent complete response [sCR], very good partial response [VGPR], partial response [PR] and overall response [CR (incl. sCR)+ VGPR + PR]) according to IMWG criteria

    To investigate other efficacy parameters of both treatment regimens

    Measured: 5 yrs

Timeline

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

  1. First posted19 Mar 2010 (estimated)
  2. Study start1 Mar 2010
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

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
348 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01090089
Sponsor's protocol ID
DSMM XIII
Acronym
DSM XIII
Status last verified
Feb 2023
First submitted
18 Mar 2010
Last updated
23 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide, Dexamethasone and Lenalidomide, Dexamethasone, PBSCT in people with Multiple Myeloma, run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 31 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 17 inclusion and 22 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 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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?

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?

Progression-free survival (PFS) (time frame: 5 yrs). 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 NCT01090089.

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 23 Feb 2023.

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