Randomized phase II Trial comparing Lenalidomide with lowdose dexamethasone versus Lenalidomide inSecond Line Multiple Myeloma (MM)

Phase 1

• Conditions: Multiple myeloma; MedDRA version: 16.1Level: LLTClassification code 10028231Term: Multiple myeloma in remissionSystem Organ Class: 100000004864; MedDRA version: 16.1Level: LLTClassification code 10028233Term: Multiple myeloma without mention of remissionSystem Organ Class: 100000004864; MedDRA version: 16.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021857-38-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 17 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 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

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.

Study & Design

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