Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma

May 12, 2015 updated by: Universitätsklinikum Hamburg-Eppendorf

Dose-finding Study of Lenalidomide as Maintenance Therapy in Multiple Myeloma After Allogeneic Stem Cell Transplantation

This study is a Phase I (non-randomized) study evaluating three dose-levels of Lenalidomide in patients after allogeneic stem cell transplantation, accomplished in two institutions (University Medical Center Hamburg-Eppendorf/ University Medical Center Heidelberg).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendorf
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Understand and voluntarily sign informed consent form
  • Age > 18 years at the time of signing the informed consent form
  • Able to adhere to the study visit schedule and other protocol requirements
  • Multiple myeloma patients who received allogeneic stem cell transplantation (100 to 180 days ago)
  • No active acute GvHD (grade II - IV)
  • No active infectious complications
  • ECOG performance status of < 2 at study entry

  • Laboratory test results within these ranges:

    • Absolute WBC count > 3.0 x 10^9/l
    • Platelet count > 80 x 10^9/l
    • Serum creatinine < 1.5 mg/dl
    • Total bilirubin < 1,5 mg/dl
    • AST (SGOT) and ALT (SGPT) < 3 x ULN
  • Females of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse for at least 28 days before starting study drug, while participating in the study and at least 28 days after discontinuation from the study.
  • male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days after discontinuation of study drug
  • disease free of prior malignancies for > 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" 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
  • use of any other experimental drug or therapy within 28 days of baseline
  • known hypersensitivity to thalidomide
  • concurrent use of other anti-cancer agents or treatments
  • known positive for HIV of infectious hepatitis, type A, B, or C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A

Lenalidomide-treatment starts between 100 and 180 days after allogeneic stem cell transplantation. Three dose-levels will be investigated.

  • Dose-level -1: 2.5 mg/d if 2.5mg capsules are available, day 1-21, otherwise 5 mg every other day, day 1-21
  • Dose-level 0: 5 mg/d, day 1-21
  • Dose-level 1: 10 mg/d, day 1-21
  • Dose-level 2: 15 mg/d, day 1-21
Drug: Revlimid (Lenalidomide)

3 pat. will be enrolled on dose level 0. If no DLTs are observed during cycles 1+2 dose will be escalated to the next higher level in the 3 patients. If 1 of 3 pat. experiences DLT at the current dose, then up to 3 more pat. will be accrued at the same level. If none of these 3 additional pat. experience DLT dose will be escalated in subsequent patients. If 1 of these 3 patients experiences DLT, the next lower level will be declared to be MTD and the study will be filled up with patients at this dose level up to 25 pat. overall.

If 2 or more of 3 pat. or 3 or more of 6 pat. in the same cohort encounter DLT, the MTD has been exceeded and the previous lower dose level will be declared as MTD and the study will be filled up with patients at this level up to 25 pat. overall.

If DLT is observed in level 0, the next dose level will be -1 for the following cohort of 3 patients. If level 2 is well tolerated without DLT, this level will be claimed as recommended dose for further trials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma
Time Frame: 2 years post-transplantation
2 years post-transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of remission status after lenalidomide treatment
Time Frame: 2 years post-transplantation
2 years post-transplantation
Effect on T-cell/ NK-cell recovery
Time Frame: 1 year post-transplantation
1 year post-transplantation
Incidence of infectious complications and GvHD
Time Frame: 1 year post-transplantation
1 year post-transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Nicolaus Kroeger, Prof. Dr., University Medical Center Hamburg-Eppendorf, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 22, 2008

First Submitted That Met QC Criteria

October 22, 2008

First Posted (Estimate)

October 23, 2008

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Revlimid as maintenance in MM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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