Dose-finding study of lenalidomide as maintenance therapy in multiple myeloma after allogeneic stem cell transplantation - Revlimid as Maintenance in MM
- Conditions
- Multiple Myeloma patients who received allogeneic stem cell transplantation (100 to 180 days ago)MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2007-003784-42-DE
- Lead Sponsor
- niversity Medical Center Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Understand and voluntarily sign an informed consent form
2. Age >18 years at the time of signing the informed consent form
3. Able to adhere to the study visit schedule and other protocol requirements
4. Multiple myeloma patients who received allogeneic stem cell transplantation (100
to 180 days ago)
5. No active acute GvHD (grade II – IV)
6. No active infectious complications
7. ECOG performance status of < 2 at study entry
8. Laboratory test results within these ranges:
•Absolute WBC count >3.0 x 10^9/l
•Platelet count > 80 x 10^9/l
•Serum creatinine < 1.5 mg/dl
•Total bilirubin < 1.5 mg/dl
•AST (SGOT) and ALT (SGPT) < 3 x ULN
9. Females of childbearing potential (FCBP) must agree to use two reliable forms of
contraception simultaneously or to practice complete abstinence from
heterosexual intercourse during the following time periods related to this study:
1) for at least 28 days before starting study drug; 2) while participating in the
study; and 3) for at least 28 days after discontinuation from the study. The two
methods of reliable contraception must include one highly effective method (i.e.
intrauterine device (IUD), hormonal [birth control pills, injections, or implants],
tubal ligation, partner’s vasectomy) and one additional effective (barrier) method
(i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified
provider of contraceptive methods if needed
10. Male subjects must agree to use a latex condom during sexual contact with
females of childbearing potential while participating in the study and for at least
28 days following discontinuation from the study even if he has undergone a
successful vasectomy
11. Disease free of prior malignancies for > 5 years with exception of currently
treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of
the cervix or breast
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
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form
2. Pregnant or breast feeding females. (Lactating females must agree not to breast
feed while taking lenalidomide)
3. Use of any other experimental drug or therapy within 28 days of baseline
4. Known hypersensitivity to thalidomide
5. Concurrent use of other anti-cancer agents or treatments
6. Known positive for HIV or infectious hepatitis, type A, B, or C
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma;Secondary Objective: • Monitoring of remission status by free-light chain assay, serum-immunoglobulin<br> and/or PCR technique (patient-specific primers)<br>• Monitoring of T-cell subpopulations and NK-cell activity after lenalidomide treatment<br>• Incidence of graft-versus-host disease.<br>;Primary end point(s): Maximale tolerable dose of Lenalidomide as maintenance therapy after allogeneic stem cell transplantation
- Secondary Outcome Measures
Name Time Method