Multiple myeloma MedDRA version: 16.1 Level: LLT Classification code 10028231 Term: Multiple myeloma in remission System Organ Class: 100000004864 MedDRA version: 16.1 Level: LLT Classification code 10028233 Term: Multiple myeloma without mention of remission System Organ Class: 100000004864 MedDRA version: 16.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be at least 18 years of age 2. Have a confirmed diagnosis of MM 3. Have received lenalidomide after one prior treatment for MM and have reached at least a partial response (PR), according to IMWG criteria, including two consolidating cycles. 4. Have personally signed and dated a legally effective written informed consent (Appendix 1) form prior to admission to the study. 5. Must be willing and able to understand and comply with the study requirements. 6. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception. 7. Male must agree to practice contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Individuals who have had a stem-cell transplant as a 2nd line treatment for MM 2. Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening. 3. Individuals with significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical condition that might affect their experience of myeloma symptoms or their ability to describe them. 4. Pregnant or lactating females 5. Any other clinically significant medical disease or condition that, in the Investigator´s opinion, may interfere with protocol adherence or a subject´s ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy (TTP) of maintenance treatment with lenalidomide alone compared to a regimen with lenalidomide and low dose dexamethasone;Secondary Objective: •To assess efficacy measured as progression free survival (PFS). •To measure time to next treatment (TNT) •To quantify the burden of maintenance treatment with lenalidomide alone compared to a regimen with lenalidomide and low dose dexamethasone. ;Primary end point(s): Time to progression (TTP);Timepoint(s) of evaluation of this end point: Continously during the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •PFS, defined as the time from randomization until objective tumor progression or death. •TNT, defined as time from inclusion to next treatment. •Safety will be studied by monitoring the occurrence of any adverse reactions and adverse events of special interest during treatment with lenalidomide; neutropenia, thrombocytopenia, acute and opportunistic infections, bleeding events, venous thromboembolism and cardiac disorders, neuropathy, rash, hypersensitivity, hypothyroidism and renal failure. ;Timepoint(s) of evaluation of this end point: Continuously during the trial | — |
Countries
Denmark, Sweden
Outcome results
None listed