Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778752
• Other study ID #: Revlimid as maintenance in MM
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 22, 2008
• Last updated: May 12, 2015
• Start date: April 2009
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma		2 years post-transplantation	Yes
Secondary	Determination of remission status after lenalidomide treatment		2 years post-transplantation	Yes
Secondary	Effect on T-cell/ NK-cell recovery		1 year post-transplantation	Yes
Secondary	Incidence of infectious complications and GvHD		1 year post-transplantation	Yes