Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma

NCT ID: NCT01090089

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-01
• Study Completion Date: 2020-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Lenalidomide, Dexamethasone, PBSCT

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Lenalidomide, Dexamethasone

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Revlimid; Revlimid

Eligibility 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.

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• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClinAssess GmbH

INDUSTRY

Sponsor Role: collaborator

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Straka

Role: PRINCIPAL_INVESTIGATOR

Agirov Klinik

Locations

Universitätsklinikum Münster

Münster, North Rhein Westfallen, Germany

Universitätsklinikum Aachen

Aachen, , Germany

Agirov Klinik

Berg, , Germany

HELIOS Klinikum Berlin-Buch

Berlin, , Germany

Evangelisches Krankenhaus Bielefeld

Bielefeld, , Germany

Klinikum Bremen-Mitte

Bremen, , Germany

Universitätsklinik Erlangen

Erlangen, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , 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

Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Stiftungsklinikum Mittelrhein gGmbH

Koblenz, , Germany

Klinikum Landshut gemeinnützige GmbH

Landshut, , Germany

Stauferklinikum Schwäbisch Gmünd

Mutlangen, , Germany

Hämato-Onkologische Schwerpunktpraxis

München, , Germany

Onkologische Praxis Elisenhof

München, , Germany

Klinikum München Harlaching

München, , Germany

Klinikum rechts der Isar

München, , Germany

Klinikum Nord

Nuremberg, , Germany

Klinikum Oldenburg

Oldenburg, , Germany

Klinikum Ernst von Bergmann gGmbH

Potsdam, , Germany

Gemeinschaftspraxis für Innere Medizin, Hämatologie und Onkologie

Ravensburg, , Germany

Klinikum der Universität Regensburg

Regensburg, , Germany

Diakonie-Klinikum Stuttgart-Diakonissenkrankenhaus und Paulinenhilfe gGmbH

Stuttgart, , Germany

Robert-Bosch-Krankenhaus

Stuttgart, , Germany

Klinikum Traunstein

Traunstein, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

HSK Dr. Horst-Schmidt-Kliniken gmbh

Wiesbaden, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Countries

Germany

Other Identifiers

DSMM XIII

Identifier Type: -

Identifier Source: org_study_id