Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma

Phase 3

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Lenalidomide, Dexamethasone, PBSCT; Drug: Lenalidomide, Dexamethasone

• Registration Number: NCT01090089
• Lead Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-01
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-19
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lenalidomid, PBSCT	Lenalidomide, Dexamethasone, 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)
Lenalidomid	Lenalidomide, Dexamethasone	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

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	5 yrs	To compare the efficacy of both treatment regimens with regard to progression-free survival.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	5 yrs	To assess the safety and overall survival of both treatment regimens.
• 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	To investigate other efficacy parameters of both treatment regimens

Trial Locations

Locations (31)

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

Agirov Klinik; 🇩🇪 Berg, Germany

Klinikum Bremen-Mitte; 🇩🇪 Bremen, Germany

Evangelisches Krankenhaus Bielefeld; 🇩🇪 Bielefeld, Germany

Klinikum Traunstein; 🇩🇪 Traunstein, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

Universitätsklinikum Münster; 🇩🇪 Muenster, North Rhein Westfallen, Germany

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

HELIOS Klinikum Berlin-Buch; 🇩🇪 Berlin, Germany

Universitätsklinik Erlangen; 🇩🇪 Erlangen, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Universitätsklinikum Göttingen; 🇩🇪 Göttingen, Germany

Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald -Anstalt öffentlichen Rechts-; 🇩🇪 Greifswald, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

Stiftungsklinikum Mittelrhein gGmbH; 🇩🇪 Koblenz, Germany

Klinikum Landshut gemeinnützige GmbH; 🇩🇪 Landshut, Germany

Hämato-Onkologische Schwerpunktpraxis; 🇩🇪 München, Germany

Stauferklinikum Schwäbisch Gmünd; 🇩🇪 Mutlangen, Germany

Onkologische Praxis Elisenhof; 🇩🇪 München, Germany

Klinikum München Harlaching; 🇩🇪 München, Germany

Klinikum Ernst von Bergmann gGmbH; 🇩🇪 Potsdam, Germany

Gemeinschaftspraxis für Innere Medizin, Hämatologie und Onkologie; 🇩🇪 Ravensburg, Germany

Klinikum Nord; 🇩🇪 Nürnberg, Germany

Klinikum Oldenburg; 🇩🇪 Oldenburg, Germany

HSK Dr. Horst-Schmidt-Kliniken gmbh; 🇩🇪 Wiesbaden, Germany

Klinikum rechts der Isar; 🇩🇪 München, Germany

Klinikum der Universität Regensburg; 🇩🇪 Regensburg, Germany

Diakonie-Klinikum Stuttgart-Diakonissenkrankenhaus und Paulinenhilfe gGmbH; 🇩🇪 Stuttgart, Germany

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany