Improve the efficacy and outcome after transplant of patients with hematologic malignancies (phase I trial) and multiple myeloma (phase II trial).

• Conditions: Allogeneic transplantation for patients with multiple myeloma; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 14.1Level: LLTClassification code 10059041Term: Allogeneic peripheral haematopoietic stem cell transplantSystem Organ Class: 100000004865; MedDRA version: 14.1Level: PTClassification code 10018651Term: Graft versus host diseaseSystem Organ Class: 10021428 - Immune system disorders

• Registration Number: EUCTR2010-018594-37-SE
• Lead Sponsor: European Myeloma Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-09
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Inclusion criteria for the phase II trial:

o High-risk multiple myeloma patients at first relapse / second complete remission candidates to receive an allogeneic transplantation
o Age: ³ 18 < 70 years.
o Suitable donor, related or unrelated (a maximum of 1 mismatched is allowed)
o Measurable disease
o High risk first relapse is defined as:
· First early relapse after ASCT (< 24 months)
· First late relapses in case the patient does not achieve CR after second ASCT
· First relapse in patients with poor cytogenetic features
o All subjects must be able to comply with the Lenalidomide Pregnancy Prevention
o Patient signs the study informed consent form
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 20
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Patient who is a known carrier of the human immunodeficiency virus (HIV), hepatitis B virus surface antigen or active infection by the hepatitis C virus (those in which the hepatitis C virus RNA can be detected).
- Patients who have experienced a myocardial infarction within 6 months prior to entry in the clinical trial or are in New York Heart Association (NYHA) functional class III or IV, heart failure, uncontrolled angina, uncontrolled ventricular arrhythmia or acute ischemia detected in the ECG, or conduction system abnormalities.
- Patients who are currently in another clinical trial or receiving any investigational agent
- Prior history of other malignant diseases other than myeloma (except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) unless the patient is disease-free longer than 5 years.
- Hypertension or poorly-controlled diabetes mellitus or any other serious organic disease involving an excessive risk to the patient or any psychiatric disorder that interferes with the understanding of the informed consent

o Prior severe comorbidity such as:
Cirhosis
· Peripheral neuropathy ³ Grade 2 14 days prior to inclusion
· Psychiatric disease
· Hypersensitivity to Bz, Boric acid manitol.
· Patients unable to use appropriate contraceptive methods
· Patients who have received an investigational drug 30 days prior to inclusion
· Patients with pericardial disease
· Patients with acute diffuse infiltrative pulmonary
· Patients not willing to comply with the Lenalidomide Pregnancy Prevention Risk Management Plan
· Patients not willing to receive thromboprophylaxis during the consolidation phase will not be eligible.

Study & Design

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