Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma

Sponsor

University of Leipzig (Other)

Overall Status

Unknown status

CT.gov ID

NCT01002703

Collaborator

Celgene Corporation (Industry), Mundipharma Pte Ltd. (Industry), Amgen (Industry)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Lenalidomide, Bendamustine, Prednisone	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Anticipated Primary Completion Date :

Oct 1, 2012

Anticipated Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RBP Lenalidomide and Bendamustine and Prednisone	Drug: Lenalidomide, 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.

Arm

Intervention/Treatment

Experimental: RBP

Lenalidomide and Bendamustine and Prednisone

Drug: Lenalidomide, 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

To determine the safety of lenalidomide, bendamustine and prednisone at MTD [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Understand and voluntarily sign an informed consent form.
Age 18 years at the time of signing the informed consent form.
Life expectancy of at least 3 months
Able to adhere to the study visit schedule and other protocol requirements
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
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.
ECOG performance status of £ 2 at study entry (see Appendix 01).
Laboratory test results within ranges
Females of childbearing potential must agree to contraception or abstinence
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:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or breast feeding females.
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.
Patients with contraindications (exclusion criteria) for treatment with lenalidomide, bendamustine and prednisone.
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).
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to thalidomide or purine analogues
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Any prior use of lenalidomide or bendamustine in the last six months
Concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.
Known positive for HIV or infectious hepatitis, type A, B or C.