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Multiple MyelomaPhase 3QUIREDEXNCT00480363

QUIREDEX: Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression

A Phase 3 study testing Maintenance with lower doses of lenalidomide and dexamethasone in people with Multiple Myeloma, run by PETHEMA Foundation at 13 sites in Spain.

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

The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM. The second one is to evaluate the efficacy of the treatment in response rate terms. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Maintenance with lower doses of lenalidomide and dexamethasone
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
13 sitesSpain
Study dates
May 2007to Jul 2013
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be able to comply with the protocol requirements
  • Must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care
  • Age ≥ 18 years
  • Patient recently diagnosed with smoldering Multiple Myeloma with high risk of progression to symptomatic Multiple Myeloma defined as follows:
  • Bone Marrow infiltration ≥ 10% CPs and M component Ig G ≥ 3 g/dl or Ig A ≥ 2 g/dl or Bence Jones Protein > 1 g/dl and absence of: hollowed out areas of bone, Hypercalcemia (Calcium-serum < 11.5 mg/dl), Renal Failure (creatinine < 2 mg/dl) and anaemia (Hb > 10 g/dl or at least 2g/dl under normal value.
  • Alternatively, patients with Bone Marrow infiltration with CPs ≥ 10 %, or Ig G ≥ 3 g/dl or Ig A ≥ 2 g/dl or Bence Jones Protein > 1 g/24h (but not the two of them together) and always without: lytic lesions, Hypercalcaemia, Renal Failure and Anaemia could be admitted with the following additional criteria:
Show all 10Show fewer
  • % CPs abnormal (CPa/CpcMO) ≥ 95 % with immunodeficiency, defined as diminution of levels of one or two Immunoglobulins of more than 25% respect normal values.
  • ECOG >= 2.
  • The patient has to be able to complain with the protocol visits.
  • Women of childbearing age must have a negative pregnancy test during the 14 days before first dose. And they must accept to use anticonceptive methods beginning during all the study until 4 weeks after the last one.

Who cannot join

  • Any other organic or mental illness that could make impossible to sign the Inform consent.
  • Patients previously received treatment to smoldering Multiple Myeloma.
  • Pregnancy or breast-feed women
  • Hollowed out areas of bone, anaemia, renal failure and Hypercalcemia
  • The following laboratory data:
  • Absolute neutrophil count ≥ 1000/mm3
Show all 14Show fewer
  • Platelet count ≥ 75000/mm3
  • Aspartate transaminase (AST) or Alanine transaminase (ALT ) ≤ 3 x the upper limit of normal.
  • Total bilirubin: ≤ 2 x the upper limit of normal.
  • Patients with >= Grade 2 peripheral neuropathy within 14 days before enrolment.
  • Patient with a previous clinical history of another malignant illness except for squamous cell carcinoma or skin cancer or cervical cancer except the patient could be free of symptoms during ≥ 5 years.
  • Patient has hypersensitivity or adverse events previous to lenalidomide or Dexamethasone.
  • Patient who has major surgery during the 4th weeks previous inclusion.
  • Patient has received other investigational drugs within 30 days before enrolment.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Spain13 sites

  • Hospital germans Trias i Pujol

    Badalona

  • Hospital Clínic i Provincial de Barcelona

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del SAS de Jerez de la Frontera

    Jerez de la Frontera

  • Hospital de la Princesa

    Madrid

  • Hospital Dode de Octubre

    Madrid

  • Hospital Ramón y Cajal

    Madrid

  • Hospital General Univeristario Morales Messeguer

    Murcia

  • Hospital Clínico de Salamanca

    Salamanca

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife

  • Hospital Clínico de Valencia

    Valencia

  • Hospital Universitario la Fe

    Valencia

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza

Other trials in Spain

About this study

Official title: QUIREDEX: A National, Open-Label, Multicenter, Randomized, Phase III Study of Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression

The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM. The second one is to evaluate the efficacy of the treatment in response rate terms. Otherwise this study wants to evaluate the safety and tolerability of the treatment

Read the detailed description

A total of up to 120 patients diagnosed of smoldering Multiple Myeloma with high risk of progression to symptomatic MM will be included.

Patients will be stratified according its diagnosis date and randomized 1 to 1 to receive Revlimid and Dexamethasone (Group A) in 9 treatment cycles and maintenance with lower doses until progression or No treatment and observation until progression (Group B).

The patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment, Treatment and Follow up.

The Pre-treatment includes Screening and baseline visits. After providing informed consent, patients will be evaluated for study eligibility and then Patients will be stratified and randomized (1:1) to Group A or Group B.

During Treatment Period patients will be evaluated once a month. Once the treatment period has finished a maintenance treatment with low doses of Revlimid and Dexamethasone will be carry out in Group A. During this period we will evaluate response, progression-free survival and global survival every two months.

Being tested
Maintenance with lower doses of lenalidomide and dexamethasone
Keywords
Smoldering Multiple Myeloma, PETHEMA, Smoldering
Medical subject headings
Multiple Myeloma, Smoldering Multiple Myeloma

What participants receive

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

  • Maintenance with lower doses of lenalidomide and dexamethasoneProcedure or surgery

    After 9 cycles of lenalidomide and dexamethasone, it follows with lower doses for maintenance

Study groups in NCT00480363
Study groupRoleWhat they receive
1ExperimentalLenalidomide + Dexamethasone for 9 cycles and maintenance
Receives: Procedure: Maintenance with lower doses of lenalidomide and dexamethasone
2No interventionObservation

What is being measured

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

  1. The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM

    Measured: one year

Secondary outcomes (2)

  1. Evaluate the efficacy of the treatment in response rate terms

    Measured: one year

  2. Evaluate the safety and tolerability of the treatment

    Measured: one year

Timeline

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

  1. First posted30 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2008
  4. Study completionJul 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00480363
Sponsor's protocol ID
2007-000649-36
Other IDs
QUIREDEX
Acronym
QUIREDEX
Status last verified
Jul 2013
First submitted
28 May 2007
Last updated
31 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • International Myeloma Working Group. Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group. Br J Haematol. 2003 Jun;121(5):749-57.

    PubMed 12780789

  • Dimopoulos MA, Moulopoulos A, Smith T, Delasalle KB, Alexanian R. Risk of disease progression in asymptomatic multiple myeloma. Am J Med. 1993 Jan;94(1):57-61. doi: 10.1016/0002-9343(93)90120-e.

    PubMed 8420300

  • Rajkumar SV. MGUS and smoldering multiple myeloma: update on pathogenesis, natural history, and management. Hematology Am Soc Hematol Educ Program. 2005:340-5. doi: 10.1182/asheducation-2005.1.340.

    PubMed 16304401

  • Wisloff F, Andersen P, Andersson TR, Brandt E, Eika C, Fjaestad K, Ly B, Lovasen K, Strom BR, Tjonnfjord GE. Has the incidence of multiple myeloma in old age been underestimated? The myeloma project of health region I in Norway. I. Eur J Haematol. 1991 Nov;47(5):333-7. doi: 10.1111/j.1600-0609.1991.tb01856.x.

    PubMed 1761118

  • Weber DM, Dimopoulos MA, Moulopoulos LA, Delasalle KB, Smith T, Alexanian R. Prognostic features of asymptomatic multiple myeloma. Br J Haematol. 1997 Jun;97(4):810-4. doi: 10.1046/j.1365-2141.1997.1122939.x.

    PubMed 9217181

  • Cesana C, Klersy C, Barbarano L, Nosari AM, Crugnola M, Pungolino E, Gargantini L, Granata S, Valentini M, Morra E. Prognostic factors for malignant transformation in monoclonal gammopathy of undetermined significance and smoldering multiple myeloma. J Clin Oncol. 2002 Mar 15;20(6):1625-34. doi: 10.1200/JCO.2002.20.6.1625.

    PubMed 11896113

  • Dimopoulos MA, Moulopoulos LA, Maniatis A, Alexanian R. Solitary plasmacytoma of bone and asymptomatic multiple myeloma. Blood. 2000 Sep 15;96(6):2037-44.

    PubMed 10979944

  • Rosinol L, Blade J, Esteve J, Aymerich M, Rozman M, Montoto S, Gine E, Nadal E, Filella X, Queralt R, Carrio A, Montserrat E. Smoldering multiple myeloma: natural history and recognition of an evolving type. Br J Haematol. 2003 Nov;123(4):631-6. doi: 10.1046/j.1365-2141.2003.04654.x.

    PubMed 14616966

  • Moulopoulos LA, Dimopoulos MA, Smith TL, Weber DM, Delasalle KB, Libshitz HI, Alexanian R. Prognostic significance of magnetic resonance imaging in patients with asymptomatic multiple myeloma. J Clin Oncol. 1995 Jan;13(1):251-6. doi: 10.1200/JCO.1995.13.1.251.

    PubMed 7799027

  • Perez-Persona E, Vidriales MB, Mateo G, Garcia-Sanz R, Mateos MV, de Coca AG, Galende J, Martin-Nunez G, Alonso JM, de Las Heras N, Hernandez JM, Martin A, Lopez-Berges C, Orfao A, San Miguel JF. New criteria to identify risk of progression in monoclonal gammopathy of uncertain significance and smoldering multiple myeloma based on multiparameter flow cytometry analysis of bone marrow plasma cells. Blood. 2007 Oct 1;110(7):2586-92. doi: 10.1182/blood-2007-05-088443. Epub 2007 Jun 18.

    PubMed 17576818

  • Hjorth M, Hellquist L, Holmberg E, Magnusson B, Rodjer S, Westin J. Initial versus deferred melphalan-prednisone therapy for asymptomatic multiple myeloma stage I--a randomized study. Myeloma Group of Western Sweden. Eur J Haematol. 1993 Feb;50(2):95-102. doi: 10.1111/j.1600-0609.1993.tb00148.x.

    PubMed 8440364

  • Rajkumar SV, Gertz MA, Lacy MQ, Dispenzieri A, Fonseca R, Geyer SM, Iturria N, Kumar S, Lust JA, Kyle RA, Greipp PR, Witzig TE. Thalidomide as initial therapy for early-stage myeloma. Leukemia. 2003 Apr;17(4):775-9. doi: 10.1038/sj.leu.2402866.

    PubMed 12682636

  • D'Amato RJ, Loughnan MS, Flynn E, Folkman J. Thalidomide is an inhibitor of angiogenesis. Proc Natl Acad Sci U S A. 1994 Apr 26;91(9):4082-5. doi: 10.1073/pnas.91.9.4082.

    PubMed 7513432

  • Geitz H, Handt S, Zwingenberger K. Thalidomide selectively modulates the density of cell surface molecules involved in the adhesion cascade. Immunopharmacology. 1996 Mar;31(2-3):213-21. doi: 10.1016/0162-3109(95)00050-x.

    PubMed 8861747

  • Haslett PA, Corral LG, Albert M, Kaplan G. Thalidomide costimulates primary human T lymphocytes, preferentially inducing proliferation, cytokine production, and cytotoxic responses in the CD8+ subset. J Exp Med. 1998 Jun 1;187(11):1885-92. doi: 10.1084/jem.187.11.1885.

    PubMed 9607928

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maintenance with lower doses of lenalidomide and dexamethasone in people with Multiple Myeloma, run by PETHEMA Foundation at 13 sites in Spain.

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 10 inclusion and 14 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 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM (time frame: one year). 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 NCT00480363, which also lists 32 linked publications.

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 31 Jul 2013.

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