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Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Revlimid (Lenalidomide)
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Stem Cell Transplantation, Revlimid, Lenalidomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Hamburg-Eppendorf
  • Universitätsklinikum Heidelberg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

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

Outcomes

Primary Outcome Measures

Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma

Secondary Outcome Measures

Determination of remission status after lenalidomide treatment
Effect on T-cell/ NK-cell recovery
Incidence of infectious complications and GvHD

Full Information

First Posted
October 22, 2008
Last Updated
May 12, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT00778752
Brief Title
Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma
Official Title
Dose-finding Study of Lenalidomide as Maintenance Therapy in Multiple Myeloma After Allogeneic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Stem Cell Transplantation, Revlimid, Lenalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Revlimid (Lenalidomide)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma
Time Frame
2 years post-transplantation
Secondary Outcome Measure Information:
Title
Determination of remission status after lenalidomide treatment
Time Frame
2 years post-transplantation
Title
Effect on T-cell/ NK-cell recovery
Time Frame
1 year post-transplantation
Title
Incidence of infectious complications and GvHD
Time Frame
1 year post-transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaus Kroeger, Prof. Dr.
Organizational Affiliation
University Medical Center Hamburg-Eppendorf, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23085463
Citation
Wolschke C, Stubig T, Hegenbart U, Schonland S, Heinzelmann M, Hildebrandt Y, Ayuk F, Atanackovic D, Dreger P, Zander A, Kroger N. Postallograft lenalidomide induces strong NK cell-mediated antimyeloma activity and risk for T cell-mediated GvHD: Results from a phase I/II dose-finding study. Exp Hematol. 2013 Feb;41(2):134-142.e3. doi: 10.1016/j.exphem.2012.10.004. Epub 2012 Oct 17.
Results Reference
derived

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Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma

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