Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma

Multiple Myeloma Clinical Trial

— DSM XIII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090089
• Other study ID #: DSMM XIII
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2010
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2023
• Source: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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)
• 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

Locations

Country	Name	City	State
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
Germany	Universitätsklinikum Göttingen	Göttingen
Germany	Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald -Anstalt öffentlichen Rechts-	Greifswald
Germany	Asklepios Klinik Altona	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Stiftungsklinikum Mittelrhein gGmbH	Koblenz
Germany	Klinikum Landshut gemeinnützige GmbH	Landshut
Germany	Universitätsklinikum Münster	Muenster	North Rhein Westfallen
Germany	Hämato-Onkologische Schwerpunktpraxis	München
Germany	Klinikum München Harlaching	München
Germany	Klinikum rechts der Isar	München
Germany	Onkologische Praxis Elisenhof	München
Germany	Stauferklinikum Schwäbisch Gmünd	Mutlangen
Germany	Klinikum Nord	Nürnberg
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

Sponsors (2)

Lead Sponsor	Collaborator
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH	ClinAssess GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	To compare the efficacy of both treatment regimens with regard to progression-free survival.	5 yrs
Secondary	Overall survival (OS)	To assess the safety and overall survival of both treatment regimens.	5 yrs
Secondary	• 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	5 yrs