enalidomide maintenance following tandem autologous stem cell and non myeloablative allogeneic transplantation for patients with multiple myeloma <= 66 years who have been treated in or according to the HOVON 65/GMMG-HD4 study. - HOVON 76 MM

Active, not recruiting

• Conditions: multiple myeloma; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2005-003891-39-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- Age 18-66 years;
- Patients with, before start (V)AD, a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria (see appendix A), included in or treated according to the HOVON 65/GMMG-HD4 study;
- Patient has received 3 cycles of (V)AD induction therapy with or without Bortezomib, CAD and 1 cycle of high dose Melphalan with autologous stem cell reinfusion;
- Patient has received a NMA allogeneic transplantation between 2 and 6 months after autologous stem cell reinfusion according to the criteria described in paragraph 8.2;
- The allogeneic transplantation has been administered between 28 and 90 days ago.
- WHO performance status 0-2 (see appendix D);
-Laboratory test results within these ranges:
* Absolute neutrophil count = 1.0 x 109/L
*Platelet count =75 x 109/L
* Serum creatinine cleareance = 50 ml/min
*Total bilirubin <= 30 µmol/l
*AST (SGOT) and ALT (SGPT) <= 3 x Upper Limit of Normal (ULN)
- Negative pregnancy test before inclusion if female of child baring potential
- Sexually active woman of child bearing potential must agree to use 2 adequate contraceptive methods while on study drug (and 4 weeks before and after study drug) (for detailed information see section 9.2.2).
- Men must agree not to father a child and agrees to use a condom if his partner is of childbearing potential.
- Disease free of prior malignancies for =5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma insitu” of the cervix or breast
- Written informed consent, preferably signed in the presence of both patient and investigator and signed on the same date.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Acute Graft versus host Disease = grade 2 (at time of registration);
- Pregnant or lactating females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or treatments.
- All subjects Patients with brain disease with the exception of those subjectspatients whose brain disease has been treated with either radiotherapy or surgery and remains asymptomatic, with no active brain disease, as shown by CT scan or MRI, for at least 6 months.
- Severe cardiac dysfunction (NYHA classification II-IV, see appendix E)
- Known positive for HIV or infectious hepatitis, type B or C

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the efficacy of low dose Lenalidomide maintenance treatment following non myeloablative Allo-SCT on Event Free Survival;Primary end point(s): Progression Free Survival of lenalidomide maintenance following non myeloablative Allo-SCT.;Secondary Objective: -To study the efficacy of low dose Lenalidomide maintenance treatment following non myeloablative Allo-SCT on Overall Survival <br>-To determine the safety of low dose Lenalidomide maintenance treatment following non myeloablative Allo-SCT including evaluation of GvHD and CTC grade toxicity (Appendix F and C)<br>-To analyse relevant immunomodulating effects of lenalidomide in Multiple Myeloma in vivo.<br>-To evaluate the response rate of low dose Lenalidomide maintenance treatment for patients not in CR before start treatment with lenalidomide.<br>