NCT00778752

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started Apr 2009

Typical duration for phase_1 multiple-myeloma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

3.9 years

First QC Date

October 22, 2008

Last Update Submit

May 12, 2015

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaStem Cell TransplantationRevlimidLenalidomide

Outcome Measures

Primary Outcomes (1)

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

    2 years post-transplantation

Secondary Outcomes (3)

  • Determination of remission status after lenalidomide treatment

    2 years post-transplantation

  • Effect on T-cell/ NK-cell recovery

    1 year post-transplantation

  • Incidence of infectious complications and GvHD

    1 year post-transplantation

Study Arms (1)

A

EXPERIMENTAL

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)

Interventions

Revlimid (Lenalidomide)DRUG

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.

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (1)

  • 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.

    PMID: 23085463DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Nicolaus Kroeger, Prof. Dr.

    University Medical Center Hamburg-Eppendorf, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

April 1, 2009

Primary Completion

March 1, 2013

Study Completion

December 1, 2013

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations

DE(2)