Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Relapsed Multiple Myeloma

NCT01421927 | Terminated Phase 1 DMC

• 2 other identifiers: CHUBX 2010/012010-023203-98
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a controversial topic because of a high risk of relapse and a significant transplant-related mortality (TRM). In an effort to reduce the TRM, most allogeneic transplants in MM are now performed after reduced-intensity conditioning regimens. In these conditions, TRM usually range from 10 to 20%. However, reducing the intensity of the conditioning invariably increases the incidence of relapse to 45 to 60%. As a consequence, post-transplant strategies to reduce the incidence of relapse after reduced-intensity Allo-SCT should be considered and evaluated.

Conditions

Multiple Myeloma

Keywords

lenalidomide

Outcome Measures

Primary Outcomes (1)

• Safety of lenalidomide

  The main judgement criteria will be the occurrence of adverse events (AE) requiring the definitive interruption of lenalidomide : * Grade 3 or 4 adverse event according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 occurring at the lowest dose of lenalidomide or * Steroid-refractory acute (Seattle criteria) or chronic (National Institutes of Health (NIH) criteria) graft versus host disease or * Transplant-related death

  1 year

Secondary Outcomes (8)

• One-year Progression-Free Survival

  one year

• One-year Overall Survival

  one year

• One-year Transplant Related Mortality

  one year

• One-year incidence of Relapse/Progression

  one year

• Incidences of acute and chronic Graft versus Host Disease

  one year

Study Arms (1)

lenalidomide

EXPERIMENTAL

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Start between Day+100 and Day+120 post-transplant \- Initial dose: 5 mg/day every day In the absence of thrombocytopenia \< 75000/mm3 or neutropenia \< 1000/mm3 (with or without G-CSF), increase to the upper level than the ongoing one every third month up to the maximal dose of 15 mg/day every day. \- Duration * until persistent stringent complete response for 3 months * or progression defined by IMWG criteria12 * or unacceptable toxicity * or one year after transplant

lenalidomide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 65 years
• Multiple Myeloma in 2nd or 3rd complete or partial response\*
• Disease never refractory to lenalidomide
• Lenalidomide treatment ≤ 9 months
• HLA related or unrelated donor (matched 10/10 or mismatched 9/10 HLA-C high resolution level or HLA-DQ high or low resolution level)
• Insured under Social Security
• Information and consent signed

You may not qualify if:

• Stable or progressive disease
• Hypersensitivity to lenalidomide or excipients
• Lenalidomide treatment \> 9 months
• Absence of efficient contraception in women or men
• Cardiac insufficiency (ejection fraction \< 50% by echocardiography)
• Pulmonary disease characterized by DLCO \< 60%
• Severe renal insufficiency (clearance of creatinin \< 30 ml/min)
• Hepatic disease characterized by ASAT and/or ALAT and/or total bilirubin \> 2 times the upper normal value except in case of Gilbert's disease
• Bacterial, Viral or Fungal uncontrolled infections
• No contraceptive method for Female subjects of childbearing potential
• No use of condoms for males subjects
• Pregnant or breast feeding woman
• History of previous cancer (other than myeloma) except if the patient is in complete remission for more than 5 years.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, 33600, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Stephane Vigouroux, Dr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Adélaïde DOUSSAU, Dr

  University Hospital, Bordeaux

  STUDY CHAIR

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: August 22, 2011
• First Posted: August 23, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 22, 2026

Record last verified: 2015-07

Locations

FR (1)