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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01002703
• Other study ID #: RBP-01/08
• Secondary ID: OSHO77
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 23, 2009
• Last updated: August 11, 2011
• Start date: September 2009
• Est. completion date: October 2014

Study information

• Verified date: October 2009
• Source: University of Leipzig
• Contact: Dietger Niederwieser
• Phone: +4934197
• Email: dietger[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 (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 stated in this treatment plan.

11. Known positive for HIV or infectious hepatitis, type A, B or C.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.

Locations

Country	Name	City	State
Germany	University of Leipzig	Leipzig

Sponsors (4)

Lead Sponsor	Collaborator
University of Leipzig	Amgen, Celgene Corporation, Mundipharma Pte Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To determine the safety of lenalidomide, bendamustine and prednisone at MTD		2 years	Yes

External Links

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