Clinical trial NCT00778752: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Stem Cell Transplantation
Revlimid
Lenalidomide
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2008-10-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma
timeFrame: 2 years post-transplantation
Secondary outcomes:
measure: Determination of remission status after lenalidomide treatment
timeFrame: 2 years post-transplantation
measure: Effect on T-cell/ NK-cell recovery
timeFrame: 1 year post-transplantation
measure: Incidence of infectious complications and GvHD
timeFrame: 1 year post-transplantation
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Germany
name: Nicolaus Kroeger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.