Multiple Myeloma
Conditions
Keywords
Lenalidomide, Bendamustine, Multiple Myeloma, Myeloma, Revlimid, Phase I/II, refractory Myeloma, relapsed Myeloma
Brief summary
Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.
Interventions
DRUGLenalidomide, Bendamustine, Prednisone
During the study the first cohort of subjects receive a starting dose of lenalidomide 10mg/d d1-21, bendamustine 60mg/m²/d d1-2 and prednisone 100mg/d d1-4. Escalation steps will include 15, 20 and 25 mg of lenalidomide and 75mg/m² for bendamustine.
Sponsors
Celgene Corporation
Mundipharma Pte Ltd.
Amgen
University of Leipzig
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Understand and voluntarily sign an informed consent form. 2. Age 18 years at the time of signing the informed consent form. 3. Life expectancy of at least 3 months 4. Able to adhere to the study visit schedule and other protocol requirements 5. Relapsed or refractory MM (only first or second relapse) in stage II or III after autologous SCT or conventional chemotherapy (histologically or cytologically proven/ Salmon and Durie criteria) with detectable myeloma protein in blood or urine 6. All previous cancer therapies, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, without corticosteroids therapy. 7. ECOG performance status of £ 2 at study entry (see Appendix 01). 8. Laboratory test results within ranges 9. Females of childbearing potential must agree to contraception or abstinence 10. Disease free of prior malignancies for ³ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma insitu of the cervix or breast
Exclusion criteria
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. 3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 4. Patients with contraindications (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerable dose (MTD) of lenalidomide in combination with bendamustine and prednisone (RBP) in refractory and relapsed MM stage I/III | 2 month |
Secondary
| Measure | Time frame |
|---|---|
| To determine the safety of lenalidomide, bendamustine and prednisone at MTD | 2 years |
Countries
Germany
Contacts
Primary ContactDietger Niederwieser
Outcome results
None listed