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

NCT01002703 | Unknown Phase 1 DMC

• 2 other identifiers: RBP-01/08OSHO77
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

Lenalidomide; Bendamustine; Multiple Myeloma; Myeloma; Revlimid; Phase I/II; refractory Myeloma; relapsed Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To determine the safety of lenalidomide, bendamustine and prednisone at MTD

  2 years

Study Arms (1)

RBP

EXPERIMENTAL

Lenalidomide and Bendamustine and Prednisone

Drug: Lenalidomide, Bendamustine, Prednisone

Interventions

Lenalidomide, Bendamustine, Prednisone DRUG

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.

RBP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Leipzig: lead
• Celgene Corporation: collaborator
• Mundipharma Pte Ltd.: collaborator
• Amgen: collaborator

Study Sites (1)

University of Leipzig

Leipzig, 04103, Germany

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Lenalidomide; Bendamustine Hydrochloride; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Butyrates; Acids, Acyclic; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Dietger Niederwieser

CONTACT

+4934197; dietger@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 27, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2014
• Last Updated: August 12, 2011

Record last verified: 2009-10

Locations

DE (1)