primary treatment of multiple myeloma patients of age 60 till 75 years MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Revlimid
Product Name: Lenalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lenalidomide
Current Sponsor code: R
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
GMIHO Gesellschaft für Medizinische Innovation – Hämatologie und Onkologie mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign an informed consent form 2. Age 60-75 years. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Symptomatic multiple myeloma requiring therapy 5. Measurable monoclonal protein present 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 > 2mg/dL or > 173 µmol/l) [A] Anemia (Hb < 10 g/dL or 2 g/dL < normal) [B] Bone lesions or general osteoporosis 8. ECOG performance status of = 2 at time of randomization 9. Laboratory test results within these ranges within 1 week prior to randomization/registration: • Absolute neutrophil count = 1.0x10e9/L • Platelet count = 75 x 10e9/L or in case of bone marrow infiltration with myeloma cells = 30x10e9/L • Total bilirubin = 2mg/dL • AST and ALT = 3xULN 10. Female subjects of childbearing potential must: o Understand the study drug has a teratogenic risk to the unborn child o Agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting lenalidomide; 2) while taking lenalidomide; 3) during dose interruptions; and 4) for at least 28 days after last dose of lenalidomide . The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. The following are examples of highly effective and additional effective methods of contraception: Examples of highly effective methods: - Intrauterine device (IUD) - Hormonal (birth control pills, injections, implants, levonorgestrel-releasing intrauterine System [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g. desogestrel])) - Tubal ligation - Partner’s vasectomy Examples of additional effective methods: - Male condom - Diaphragm - Cervical Cap o Agree to have two medically supervised negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to starting lenalidomide. The first pregnancy test must be performed within 10 to 14 days prior to the start of lenalidomide and the second pregnancy test must be performed within 24 hours prior to the start of lenalidomide. The patient may not receive lenalidomide until the study doctor has verified that the results of these pregnancy tests are negative. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. The test should ensure the subject is not pregnant when she starts treatment. o Agree to have a medically supervised pregnancy test weekly for the first 28 days of study participation and then every 28 days while taking lenalidomide, at study discontinuation, and at day 28 following the last dose of lenalidomide. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days of study participation and then every 14 days while taking lenalidomide, at study discontinuation, and at days 14 and 28 following the last dose of lenalidomide. o Should not donate blood while receiving lenalidomide, during dose interruptionsand for at least 28 days after the last dose of lenalidomide. o Counseling about pregnancy precau
Exclusion criteria
Exclusion criteria: 1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant or lactating females 3. Any condition, including 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 in such a study within 4 weeks before randomization and/or is receiving an investigational agent for any reason or has received such an agent within 4 weeks before randomization/registration 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, with the exception of radiotherapy to restricted areas 9. Known positive for HIV; active or chronic hepatitis A, B or C infection (including patients who are tested anti-HBc positive and/or HBsAg positive) - serological testing for hepatitis A, B, C required 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 for symptom control 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/registration, 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 < 50% of normal) 17. Treatment for cancer other than multiple myeloma 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of both treatment regimens with regard to progression-free survival.;Secondary Objective: • To assess the safety and overall survival of both treatment regimens. • To investigate other efficacy parameters of both treatment regimens.;Primary end point(s): progression-free survival (PFS) from the time point of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival (OS) - Response (complete response [CR], stringent complete response [sCR] very good partial response [VGPR], partial response [PR], and overall response [CR (including sCR) + VGPR + PR]) according to IMWG criteria (27). - Duration of response - Time to response - Safety (adverse events, laboratory abnormalities, and hospitalizations) - Time to treatment failure (TTF) - Time to progression (TTP) - Time to second-line anti-myeloma treatment - Relationship of cytogenetic findings in the malignant myeloma clone at baseline to clinical outcomes | — |
Countries
Germany
Contacts
Public ContactGMIHO
GMIHO Gesellschaft für Medizinische Innovation – Hämatologie und Onkologie mbH
Outcome results
None listed