Treatment with Lenalidomide, Bendamustine and Prednisone (RBP) in Patients with Relapsed or Refractory Multiple Myeloma after Autologous Stem Cell Transplantation or Conventional Chemotherapy OSHO #077 - OSHO #077
- Conditions
- Relapsed or refractory Multiple MyelomaMedDRA version: 18.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
- Registration Number
- EUCTR2008-001885-96-DE
- Lead Sponsor
- niversity of Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
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 (histological or cytological proven/ Salmon and Durie criteria) with detectable myeloma protein in blood or urine
6.All previous cancer therapy, 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.
8.Laboratory test results within these ranges:
•Absolute neutrophil count = 1.5 x 10 9/L
•Platelet count = 100 x 109/L
•GFR = 50 ml/min
•Total bilirubin = 1.5 mg/dl
•AST (SGOT) and ALT (SGPT) = 2 x ULN or = 5 x ULN if hepatic metastases are present.
9.Disease free of prior malignancies for = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma insitu” of the cervix or breast
10.Female subjects of childbearing potential must:
o Understand that the study medication could have a potential teratogenic risk
o Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception
?Implant
?Levonorgestrel-releasing intrauterine system (IUS)
?Medroxyprogesterone acetate depot
?Tubal sterilisation
?Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
?Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
o Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days from the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
o Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
•Male subjects must
o Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
o Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
•All subjects must
o Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
o Agree not to share study medication with another person and to return all unused study drug to the investigator
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
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 (exclusion criteria) for treatment with lenalidomide, bendamustine and prednisone.
5. Uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (= Lown 3).
6. Use of any other experimental drug or therapy within 28 days of baseline.
7. Known hypersensitivity to thalidomide or purine analogues
8. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
9. Any prior use of lenalidomide or bendamustine in the last six months
10. Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan.
11. 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: Phase I:<br>To determine the maximum tolerable dose (MTD) of lenalidomide in combination with bendamustine and prednisone (RBP) in refractory and relapsed Multipla Myeloma stage II/III<br>Phase II:<br>To determine the safety of lenalidomide, bendamustine and prednisone at MTD<br>;Secondary Objective: •To assess the efficacy of RBP as treatment for subjects with relapsed or refractory multiple myeloma stage II or III by estimating the objective response rate (CR, nCR, VGPR, PR, MR) <br>•To assess the progression-free-survival <br>•To assess the overall survival at 18 months<br>;Primary end point(s): Phase I:<br>•Define MTD of the combination lenalidomide/bendamustine/prednisone<br>Phase II:<br>•Safety (type, frequency, severity, and relationship of adverse events to study therapy)<br>
- Secondary Outcome Measures
Name Time Method