NCT01352338

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline
Completed

Started Aug 2011

Typical duration for phase_1 multiple-myeloma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

3.3 years

First QC Date

April 13, 2011

Last Update Submit

February 25, 2016

Conditions

Multiple Myeloma

Keywords

REPEATmultiple myelomarevlimidlenalidomidecyclophosphamideendoxanprednisonelenalidomide refractory

Outcome Measures

Primary Outcomes (1)

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

    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

    29 days after start of treatment cycle 1

Secondary Outcomes (4)

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

    29 days after start of treatment cycle 1

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

    28 days

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

    28 days

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

    28 days

Study Arms (1)

lenalidomide, endoxan, prednisone

EXPERIMENTAL

lenalidomide 25mg, oral therapy, once a day, 4 weeks cycles. Lenalidomide is used 3 of the 4 weeks. Lenalidomide is combined with endoxan and prednisone

Drug: Lenalidomide, endoxan, prednisone

Interventions

lenalidomide, endoxan, prednisoneDRUG

dose-finding

Also known as: revlimid combined with endoxan and prednisone
lenalidomide, endoxan, prednisone

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Antonius Ziekenhuis Nieuwegein

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

UMC Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

Location

VU Medical Center

Amsterdam, Netherlands

Location

Related Publications (1)

  • Nijhof IS, Franssen LE, Levin MD, Bos GMJ, Broijl A, Klein SK, Koene HR, Bloem AC, Beeker A, Faber LM, van der Spek E, Ypma PF, Raymakers R, van Spronsen DJ, Westerweel PE, Oostvogels R, van Velzen J, van Kessel B, Mutis T, Sonneveld P, Zweegman S, Lokhorst HM, van de Donk NWCJ. Phase 1/2 study of lenalidomide combined with low-dose cyclophosphamide and prednisone in lenalidomide-refractory multiple myeloma. Blood. 2016 Nov 10;128(19):2297-2306. doi: 10.1182/blood-2016-07-729236. Epub 2016 Sep 19.

    PMID: 27647864DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

LenalidomideCyclophosphamidePrednisone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Dr. N.C.W.J. Donk, van de, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs

Study Record Dates

First Submitted

April 13, 2011

First Posted

May 11, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2014

Study Completion

February 1, 2016

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

NL(3)