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

March 18, 2010
June 17, 2014
March 2010
January 2015   (final data collection date for primary outcome measure)
Progression-free survival (PFS) [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01090089 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma
The Combination of Lenalidomide and Dexamethasone With or Without Intensification by High-dose Melphalan in the Treatment of Multiple Myeloma

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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
  • 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
  • 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)
    Intervention: Drug: Lenalidomide, Dexamethasone, PBSCT
  • 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
    Intervention: Drug: Lenalidomide, Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
376
April 2015
January 2015   (final data collection date for primary outcome measure)

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.

    -

Both
60 Years to 75 Years
No
Contact: Christian Straka +49-8151-17 806 cstraka@schoen-kliniken.de
Germany
 
NCT01090089
DSMM XIII
No
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
ClinAssess GmbH
Principal Investigator: Christian Straka Agirov Klinik
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP