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Multiple MyelomaPhase 1/2REPEATNCT01352338

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

A Phase 1/2 study testing Lenalidomide, endoxan, prednisone in people with Multiple Myeloma, run by UMC Utrecht at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Lenalidomide, endoxan, prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
3 sitesNetherlands
Study dates
Aug 2011to Feb 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • VU Medical Center

    Amsterdam

  • Antonius Ziekenhuis Nieuwegein

    Nieuwegein, Utrecht, 3435 CM

  • UMC Utrecht

    Utrecht, Utrecht, 3584CX

Other trials in Netherlands

About this study

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

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

Read the detailed description

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.

Being tested
Lenalidomide, endoxan, prednisone
Keywords
REPEAT, multiple myeloma, revlimid, lenalidomide, cyclophosphamide, endoxan, prednisone, lenalidomide refractory
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lenalidomide, endoxan, prednisoneDrug

    Also called revlimid combined with endoxan and prednisone

    dose-finding

  • lenalidomide, endoxan, prednisoneDrug

    Also called revlimid combined with cyclophosphamide and prednisone

    oral therapy with lenalidomide 25mg a day during 3 of 4 week cycles. Number of Cycles: until progression or unacceptable toxicity develops.

Study groups in NCT01352338
Study groupRoleWhat they receive
lenalidomide, endoxan, prednisoneExperimentallenalidomide 25mg, oral therapy, once a day, 4 weeks cycles. Lenalidomide is used 3 of the 4 weeks. Lenalidomide is combined with endoxan and prednisone
Receives: Drug: Lenalidomide, endoxan, prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 29 days after start of treatment cycle 1

Secondary outcomes (4)

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

    number of participants with adverse events

    Measured: 29 days after start of treatment cycle 1

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

    • to evaluate progression-free survival

    Measured: 28 days

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

    • to evaluate overall survival

    Measured: 28 days

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

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

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionNov 2014
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01352338
Sponsor's protocol ID
RV-MM-PI-0630
Acronym
REPEAT
Status last verified
Feb 2016
First submitted
13 Apr 2011
Last updated
26 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27647864

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide, endoxan, prednisone in people with Multiple Myeloma, run by UMC Utrecht at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT) (time frame: 29 days after start of treatment cycle 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01352338, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.

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