Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma

NCT01090089 | Completed Phase 3

• 1 other identifier: DSMM XIII
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 31

Brief 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 transplantation.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

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

  5 yrs

Secondary Outcomes (2)

• Overall survival (OS)

  5 yrs

• • 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

  5 yrs

Study Arms (2)

Lenalidomid, PBSCT

EXPERIMENTAL

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

Lenalidomid

ACTIVE COMPARATOR

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

Interventions

Lenalidomide, Dexamethasone DRUG

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

Also known as: Revlimid

Lenalidomid

Lenalidomide, Dexamethasone, PBSCT DRUG

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

Also known as: Revlimid

Lenalidomid, PBSCT

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH: lead
• ClinAssess GmbH: collaborator

Study Sites (31)

Universitätsklinikum Münster

Münster, North Rhein Westfallen, 48149, Germany

Location

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

Agirov Klinik

Berg, 82335, Germany

Location

HELIOS Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Evangelisches Krankenhaus Bielefeld

Bielefeld, 33611, Germany

Location

Klinikum Bremen-Mitte

Bremen, 28177, Germany

Location

Universitätsklinik Erlangen

Erlangen, 91054, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Göttingen

Göttingen, 37075, Germany

Location

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

Greifswald, 17475, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Stiftungsklinikum Mittelrhein gGmbH

Koblenz, 56068, Germany

Location

Klinikum Landshut gemeinnützige GmbH

Landshut, 84034, Germany

Location

Stauferklinikum Schwäbisch Gmünd

Mutlangen, 73557, Germany

Location

Hämato-Onkologische Schwerpunktpraxis

München, 80331, Germany

Location

Onkologische Praxis Elisenhof

München, 80335, Germany

Location

Klinikum München Harlaching

München, 81545, Germany

Location

Klinikum rechts der Isar

München, 81675, Germany

Location

Klinikum Nord

Nuremberg, 90419, Germany

Location

Klinikum Oldenburg

Oldenburg, 26133, Germany

Location

Klinikum Ernst von Bergmann gGmbH

Potsdam, 14467, Germany

Location

Gemeinschaftspraxis für Innere Medizin, Hämatologie und Onkologie

Ravensburg, 88214, Germany

Location

Klinikum der Universität Regensburg

Regensburg, 93053, Germany

Location

Diakonie-Klinikum Stuttgart-Diakonissenkrankenhaus und Paulinenhilfe gGmbH

Stuttgart, 70176, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Klinikum Traunstein

Traunstein, 83278, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

HSK Dr. Horst-Schmidt-Kliniken gmbh

Wiesbaden, 65199, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Dexamethasone; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Christian Straka

  Agirov Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 19, 2010
• Study Start: March 1, 2010
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

DE (31)