A study of the efficacy and safety of the drug lenalidomide used alone compared with lenalidomide together with a low dose of the drug dexamethasone in patients with the blood cell tumor disease multiple myeloma (MM) who have failed on the first therapy

Phase 1

• Conditions: Multiple myeloma; MedDRA version: 17.0Level: LLTClassification code 10028231Term: Multiple myeloma in remissionSystem Organ Class: 100000004864; MedDRA version: 17.0Level: LLTClassification code 10028233Term: Multiple myeloma without mention of remissionSystem Organ Class: 100000004864; MedDRA version: 17.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021857-38-DK
• Lead Sponsor: Karolinska University Hospital/Huddinge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-12
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 leagally effective written informed consent 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

1. Individuals who have had a stem-cell transplant as a 2nd line treatment for MM
2. ECOG performance status <4
3. Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening
4. Individuals whth 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
5. Pregnant or lactating females
6. Any other clinically significant medical disease or condition that, in the Investigator´s opinion, may interfere with protocol adherence or a subjects´s ability to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess efficacy (TTP) of maintenance treatment with lenlidomide alone compared to a regimen with lenalidomide and low dose dexamethasone;Secondary Objective: - To assess efficacy measured as progression free survival (PFS)<br>- To measure time to next treatment (TNT)<br>- 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: Continuously during the trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - PFS, defined as the time from randomization until objective progression or death.<br>- TNT, defined as time from inclusion to next treatment.<br>- Safety will be studied by monitoring the occurrence of any adverse reactions and adverse events of special interest during trreatment with lenalidomide; neutropenia, thrombocytopenia, acute and opportunistic infections, bleeding events, venous thromoboembolism and cardiac disorders, neuropathy, rash, hypersensitivity, hypothyroidism and renal failure.;Timepoint(s) of evaluation of this end point: Continuously during the trial