Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma (DSM XIII)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Sponsor:
Collaborator:
ClinAssess GmbH
Information provided by (Responsible Party):
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
ClinicalTrials.gov Identifier:
NCT01090089
First received: March 18, 2010
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Lenalidomide, Dexamethasone
Drug: Lenalidomide, Dexamethasone, PBSCT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Combination of Lenalidomide and Dexamethasone With or Without Intensification by High-dose Melphalan in the Treatment of Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
  • • 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 [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 376
Study Start Date: March 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomid, PBSCT
A1 Rd until progression or max. 5 years (Rd = lenalidomide 25 mg d1-21/28d + dexamethasone 40 mg po d1, d8, d15, d22/28d)
Drug: Lenalidomide, Dexamethasone, PBSCT
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
Other Name: Revlimid
Active Comparator: Lenalidomid
A2 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
Drug: Lenalidomide, Dexamethasone
Rd until progression or max. 5 years (Rd = lenalidomide 25 mg d1-21/28d + dexamethasone 40 mg po d1, d8, d15, d22/28d)
Other Name: Revlimid

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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,...

    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.

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF.
  2. Pregnant or lactating females
  3. 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.
  4. 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 ...
  5. Known hypersensitivity to thalidomide, dexamethasone, or melphalan.
  6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  7. Any prior use of lenalidomide.
  8. Concurrent use of other anti-cancer agents or treatments.
  9. Known positive for HIV or active infectious hepatitis, type A, B or C or treponema pallidum
  10. Prior treatment with dexamethasone discontinued because of ≥ grade 3 dexamethasone-related toxicity.
  11. Any prior chemotherapy with the exception of a short course of dexamethasone more than 4 weeks before randomization.
  12. Immunotherapy or antibody therapy within 8 weeks before randomization.
  13. Major surgery within 4 weeks before randomization.
  14. Renal failure requiring dialysis.
  15. 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.
  16. Severe pulmonary disease (diffusion capacity < 60% of normal).
  17. Treatment for cancer other than MM within 5 years before randomization, with the exception of basal cell carcinoma or cervical cancer in situ.
  18. Cardiac amyloidosis.
  19. 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.
  20. Any systemic infection requiring treatment.
  21. Unability or unwillingness of the patient to receive antithrombotic prophylaxis.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090089

Contacts
Contact: Christian Straka +49-8151-17 806 cstraka@schoen-kliniken.de

Locations
Germany
Universitätsklinikum Münster Recruiting
Muenster, North Rhein Westfallen, Germany, 48149
Contact: Martin Kropff, PD Dr. med.    0251-8347590    martin.kropff@ukmuenster.de   
Universitätsklinikum Aachen Recruiting
Aachen, Germany, 52074
Contact: Tim H. Brümmendorf, Prof. Dr.    0241 / 80-89805    tbruemmendorf@ukaachen.de   
Agirov Klinik Recruiting
Berg, Germany, 82335
Contact: Christian Straka, PD Dr. med.    +49-0815117806    cstraka@schoen-kliniken.de   
HELIOS Klinikum Berlin-Buch Recruiting
Berlin, Germany, 13125
Contact: Christian Gerecke, Dr. med.    +49-030 9401 12 190    christian.gerecke@helios-kliniken.de   
Evangelisches Krankenhaus Bielefeld Not yet recruiting
Bielefeld, Germany, 33611
Contact: Eva Bettina Zinngrebe, MD    05 21 / 772-75750    Bettina.Zinngrebe@evkb.de   
Klinikum Bremen-Mitte Recruiting
Bremen, Germany, 28177
Contact: Bernd Hertenstein, Prof. Dr.    +49-421-4975240    bernd.hertenstein@klinikum-bremen-mitte.de   
Universitätsklinik Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Wolf Rösler, Dr. med.         
Contact    +49-9131-85 36991    wolf.roesler@uk-erlangen.de   
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Monika Engelhardt, Prof. Dr.    +49-7 612 70 - 34 61    monika.engelhardt@uniklinik-freiburg.de   
Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald -Anstalt öffentlichen Rechts- Not yet recruiting
Greifswald, Germany, 17475
Contact: Gottfried Dölken, Prof. Dr.    03834-86-6698    doelken@uni-greifswald.de   
Universitätsklinikum Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Wolfram Jung, Dr. med.    +49-551-39 8558    wolfram.jung@med.uni-goettingen.de   
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Georgia Schilling, Dr. med.    +49-40-741055692    g.schilling@uke.uni-hamburg.de   
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Contact: Hans Salwender, Dr. med.    +49-40- 181881-1211    h.salwender@asklepios.com   
Universitätsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Contact: Martin Gramatzki, Prof. Dr.    0431-597 5802    m.gramatzki@med2.uni-kiel.de   
Stiftungsklinikum Mittelrhein gGmbH Recruiting
Koblenz, Germany, 56068
Contact: Ralph Naumann, Prof. Dr.       ralph.naumann@stiftungsklinikum.de   
Klinikum Landshut gemeinnützige GmbH Recruiting
Landshut, Germany, 84034
Contact: Juliana Ababei, Dr. med.    +49-871-698-0    juliana.ababei@klinikum-landshut.de   
Stauferklinikum Schwäbisch Gmünd Recruiting
Mutlangen, Germany, 73557
Contact: Holger Hebart, Prof. Dr.    +49- 07171-701-1302    holger.hebart@stauferklinikum.de   
Klinikum rechts der Isar Recruiting
München, Germany, 81675
Contact: Tobias Dechow, PD Dr. med.    +49-89-4140 5834    t.dechow@lrz.tum.de   
Klinikum München Harlaching Recruiting
München, Germany, 81545
Contact: Marcus Hentrich, PD Dr. med.    089-62102663    tumorzentrum.hentrich@khmh.de   
Onkologische Praxis Elisenhof Recruiting
München, Germany, 80335
Contact: Peter Bojko, PD Dr. med.    +49-89- 452256-0    p.bojko@onkologie-elisenhof.de   
Hämato-Onkologische Schwerpunktpraxis Not yet recruiting
München, Germany, 80331
Contact: Jochem Walther, Dr. med.    089554416    jochenwalther@gmx.de   
Klinikum Nord Recruiting
Nürnberg, Germany, 90419
Contact: Hannes Wandt, Prof. Dr.    +49-911-398 3650    Hannes.Wandt@klinikum-nuernberg.de   
Klinikum Oldenburg Recruiting
Oldenburg, Germany, 26133
Contact: Bernd Metzner, Dr. med.    +49-441-403 72955    metzner.bernd@klinikum-oldenburg.de   
Klinikum Ernst von Bergmann gGmbH Recruiting
Potsdam, Germany, 14467
Contact: Georg Maschmeyer, Prof. Dr.    0331-241-6001    gmaschmeyer@klinikumevb.de   
Gemeinschaftspraxis für Innere Medizin, Hämatologie und Onkologie Recruiting
Ravensburg, Germany, 88214
Contact: Thomas Decker, PD Dr. med.    +49 751/ 36650-35    decker@onkonet.eu   
Klinikum der Universität Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Albrecht Reichle, Prof. Dr.    +49-941-944 5541    albrecht.reichle@klinik.uni-regensburg.de   
Diakonie-Klinikum Stuttgart-Diakonissenkrankenhaus und Paulinenhilfe gGmbH Recruiting
Stuttgart, Germany, 70176
Contact: Else Heidemann, Prof. Dr.    +49-711-991-3501    heidemann@diak-stuttgart.de   
Robert-Bosch-Krankenhaus Recruiting
Stuttgart, Germany, 70376
Contact: Martin Kaufmann, Dr. med.    0711-8101-3174    martin.kaufmann@rbk.de   
Klinikum Traunstein Recruiting
Traunstein, Germany, 83278
Contact: Thomas W Kubin, Dr. med.    +49-861-705 1243    thomas.kubin@klinikum-traunstein.de   
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89081
Contact: Christian Langer, Dr. med.    +49-731-500-45743    christian.langer@uniklinik-ulm.de   
HSK Dr. Horst-Schmidt-Kliniken gmbh Recruiting
Wiesbaden, Germany, 65199
Contact: Norbert Frickhofen, Prof. Dr.    +49- 611-43-3009    norbert.frickhofen@hsk-wiesbaden.de   
Universitätsklinikum Würzburg Recruiting
Würzburg, Germany, 97080
Contact: Stefan Knop, PD Dr. med.    +49-931-20170800    knop_s@medizin.uni-wuerzburg.de   
Sponsors and Collaborators
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
ClinAssess GmbH
Investigators
Principal Investigator: Christian Straka Agirov Klinik
  More Information

No publications provided

Responsible Party: Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
ClinicalTrials.gov Identifier: NCT01090089     History of Changes
Other Study ID Numbers: DSMM XIII
Study First Received: March 18, 2010
Last Updated: June 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on September 18, 2014