Skip to main content
OpenTrials
Completed

NCT Number: NCT01352338

Revlimid, Endoxan, Prednison Evaluation After Prior Revlimid Treatment (REPEAT)

Study Phase: phase 1 and phase 2

Objective: Evaluation of the effect of lenalidomide, cyclophophamide and prednisone (REP) in patients with relapsed multiple myeloma previously treated with lenalidomide

Study design: prospective, multicenter, non-randomized

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Antonius Ziekenhuis Nieuwegein, Nieuwegein, Utrecht, Netherlands

Loading trial locations.

About this study

The REPEAT-study is a prospective, multicenter, non-randomized phase 1 and phase 2 study in which we evaluate the effect of lenalidomide, cyclophosphamide and prednisone (REP-therapy) in patients with relapsed multiple myeloma, previously treated with lenalidomide and refractory to lenalidomide monotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • salmon & Durie stage II/III A or B
  • previous lenalidomide refractory disease
  • patient commits to pregnancy prevention programme

Exclusion criteria

  • non-secretory myeloma
  • known hypersensitivity to lenalidomide
  • inadequate marrow reserve

Treatment and study plan

Lenalidomide, endoxan, prednisone

Drug

dose-finding

Other names: revlimid combined with endoxan and prednisone

Primary outcomes

  1. Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT)

    Time frame: 29 days after start of treatment cycle 1

    To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 weeks cycle, combined with continuous cyclophosphamide and prednisone

Secondary outcomes

  1. phase 1 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)

    Time frame: 29 days after start of treatment cycle 1

    number of participants with adverse events

  2. phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)

    Time frame: 28 days

    • to evaluate progression-free survival

  3. phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)

    Time frame: 28 days

    • to evaluate overall survival

  4. phase 2 part of the study Revlimid, Endoxan, Prednison Evaluation After prior revlimid Treatment (REPEAT)

    Time frame: 28 days

    • to evaluate the immunomodulatory effects of lenalidomide by using flow cytometric and cytokine analysis

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Celgene Corporation

Registry information

Official study title

A Phase 1 and Phase 2 Study of Lenalidomide (Revlimid) in Combination With Cyclophosphamide (Endoxan) and Prednison (REP) in Relapsed/Refractory Multiple Myeloma

Acronym: REPEAT

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
May 11, 2011
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.