Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Revlimid (Lenalidomide)

• Registration Number: NCT00778752
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-23
• Study Start: 2009-04
• Primary Completion: 2013-03
• Study Completion: 2013-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Revlimid (Lenalidomide)	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

Primary Outcome Measures

Name	Time	Method
Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma	2 years post-transplantation

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany