Multiple Myeloma (1.-3. Progression/Relapse) MedDRA version: 20.0 Level: LLT Classification code 10067095 Term: Multiple myeloma progression System Organ Class: 100000054086
Conditions
Interventions
Trade Name: Revlimid®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5
Sponsors
University Hospital Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: signed informed consent (age =18 years at time of signature); age =18 years and =75 years at time of randomization (requirement for inclusion of patients =71 years old: adequate autologous hematopoetic stem cells of former mobilization to be available at trial inclusion date); must be able to adhere to the study visit schedule and other protocol requirements; patients with relapsed Multiple Myeloma (1.-3. progression/relapse) Salmon-Durie-Stage II or III or symptomatic Myeloma (according to IMWG criteria) requiring systemic therapy; WHO Performance Status =2 at time of inclusion in study; results of laboratory assessments at time of inclusion within the following ranges: Absolute neutrophil count =1.0 x 10^9/L, Platelet count =75 x 10^9/L or, dependent on bone marrow infiltration by plasma cells, platelet count =30x 10^9/L, Creatinine-Clearance =30mL/min, serum total bilirubin =2 x ULN, ALT (SGPT) =3 x ULN; adhere to requirements of Pregnancy Prevention Program; prior history of other malignancy, unless the patient has been free of the disease for =5years (exceptions include: basal cell carcinoma, carcinoma in situ of skin, carcinoma in situ of cervix or breast); ability to perform thromboprophylaxis with low molecular weight heparin; patients, who received high-dose chemotherapy and autologous stem cell transplantation in first-line therapy are eligible if they had no disease progression/relapse =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Pregnant or breast feeding females; non-secretory Myeloma (with normal FLC-ratio), from which no measurable myeloma manifestations are detectable by radiological assessment; systemic AL-Amyloidosis with organ involvement (except for AL-Amyloidosis of skin and/or bone marrow); patients who received treatment with any non-market drug substance within 28 days prior to start of study treatment; known hypersensitivity to thalidomide, lenalidomide (Revlimid) or to any constituent compounds of Revlimid (e.g. lactose); development of erythema nodosum, if characterized by a desquamating rash while taking thalidomide or similar drugs; patients with active uncontrolled infection; known positivity for HIV or clinically active Hepatitis B or C; heart insufficiency NYHA =3; any serious pulmonary, neurological or psychiatric disease; patients with Plasma cell leukemia; previous allogenic transplantation; in case of previous therapy with Lenalidomide: - No response (stable disease) or PD on or =60days after completion of treatment with Lenalidomide, - In case of prior response = MR: PD =6months after completion of treatment with Lenalidomide; patients who received salvage autologous transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proof of significant prolongation of the progression-free survival (PFS, time from randomization until disease progression or death from any cause) through an induction therapy with Lenalidomide/Dexamethasone followed by high-dose chemotherapy with Melphalane, autologous blood stem cell transplantation and maintenance therapy with Lenalidomide in contrast to conventional therapy with Lenalidomide/Dexamethasone.;Secondary Objective: Overall survival (OS, time from randomization until death from any cause or date last contact); response rate (MR, PR, VGPR, CR); time to best response; will the achievement of CR/VGPR before transplantation result in prolongation of PFS and OS; will the achievement of CR/VGPR before start of maintenance result in prolongation of PFS and OS; is there a prolongation of OS in patients receiving salvage transplantation followed by Lenalidomide maintenance earlier compared to patients receiving salvage transplantation at later time; feasibility of stem cell collection; assessment of safety and toxicity; time to initiation of new myeloma treatment.;Primary end point(s): progression-free survival (time from randomization to disease progression or death from any cause);Timepoint(s) of evaluation of this end point: progression-free survival (i.e., time from randomization to progression or death from any cause whichever occurs first). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - overall survival (defined as time from randomization to death from any cause) - response rates - toxicity;Timepoint(s) of evaluation of this end point: overall survival, toxicity: any time response: -Arm A: after 3.+5.cycle Rd, thereafter every 3 months -Arm B: after 3. cycle Rd, after high-dose chemotherapy, during maintenance every 3 months | — |
Countries
Germany
Contacts
Public ContactGMMG-Studiensekretariat
GMMG Study Office
Outcome results
None listed