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Multiple MyelomaPhase 3NCT00443235

GEM05 for Patients With Multiple Myeloma More Than 65 Years Old

A Phase 3 study testing Melphalan/Prednisone/Velcade and Thalidomide/Prednisone/Velcade in people with Multiple Myeloma, run by PETHEMA Foundation at 77 sites in Spain.

Completed

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

Official record
Search all trials

Trial summary

The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments Read more about this study

Who is it for?
Ages 66 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Melphalan/Prednisone/Velcade and Thalidomide/Prednisone/Velcade
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
77 sitesSpain
Study dates
Mar 2005to Dec 2009
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 66 years and older
  • All sexes
  • No healthy volunteers
  • 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before performance of any study-related procedure not part of normal medical care, with the understanding it can be withdrawn at any time without prejudice to future medical care.
  • Age > 65 years.
  • Patient recently diagnosed with symptomatic Multiple Myeloma based on standard criteria28 and that has not received any previous chemotherapy treatment for Multiple Myeloma Some steroid doses or bisphosphonates are allowed for emergencies before starting induction treatment.
  • Patient has measurable disease, defined as follows:
  • For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours.
Show all 11Show fewer
  • Patient has a ECOG performance status < 2
  • Patient has a life-expectancy >3 months.
  • Patient has the following laboratory values before beginning induction treatment:
  • Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g/dl and absolute neutrophil count ≥ 1000/mm3. Lower values are allowed if they are due to marrow infiltration.
  • Corrected serum calcium <14mg/dl. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. Total bilirubin: ≤1.5 x the upper limit of normal. Serum creatinine ≤ 2 mg/dl.

Who cannot join

  • Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates.
  • Non-secretor Myeloma
  • Patients with < Grade 2 peripheral neuropathy within 14 days before enrolment.
  • Patient had major surgery within 4 weeks before enrolment.
  • Patient has hypersensitivity to bortezomib, boron or mannitol.
  • Patient has received other investigational drugs within 30 days before enrolment.
Show all 9Show fewer
  • Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection.
  • Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

Spain77 sites

  • Complejo Hospitalario Universitario de Albacete

    Albacete

  • Fundación Hospital Alcorcón

    Alcorcón

  • Hospital Nuestra Señora de Sonsoles

    Ávila

  • Hospital Regional Universitario Infanta Cristina

    Badajoz

  • Hospital de Badalona Germans Trias i Pujol

    Badalona

  • Hospital Clinic i Provincial de Barcelona

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Vall D'Hebron

    Barcelona

  • Hospital de Basurto

    Basurto

  • Hospital de Cruces

    Bilbao

  • Hospital Virgen del Puerto

    Cáceres

  • Hospital General de Castellón

    Castellon

  • Hospital Nuestra Señora de Alarcos

    Ciudad Real

  • Hospital Virgen de la Luz

    Cuenca

  • Hospital Donostia

    Donostia / San Sebastian

  • Hospital General de Elda

    Elda

  • Hospital Universitario de Getafe

    Getafe

  • Institut Català d'Oncologia,

    Girona

  • Hospital General de Guadalajara

    Guadalajara

  • Hospital de San Jorge

    Huesca

  • Hospital General de Lanzarote

    Lanzarote

  • Complejo Hospitalario Xeral-Calde

    Lugo

  • Clínica Moncloa

    Madrid

  • Clínica Puerta de Hierro

    Madrid

  • Clínica Rúber

    Madrid

  • Fundación Jiménez Díaz

    Madrid

  • Hospital Central de la Defensa

    Madrid

  • Hospital Clínico Universitario San Carlos

    Madrid

  • Hospital Doce de Octubre

    Madrid

  • Hospital Ramón y Cajal

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario La Princesa

    Madrid

  • Althaia, Xarxa Asistencial de Manresa

    Manresa

  • Fundación Hospital Sant Joan de Déu de Martorell

    Martorell

  • Hospital de Mérida

    Mérida

  • Hospital de Móstoles

    Móstoles

  • Hospital General Morales Meseguer

    Murcia

  • Hospital Santa María del Rosell

    Murcia

  • Hospital Virgen del Castillo de Yecla

    Murcia

  • Hospital de Gran Canaria Doctor Negrín

    Palma de Gran Canaria

  • Complejo Asistencial Son Dureta

    Palma de Mallorca

  • Hospital Son Llatzer

    Palma de Mallorca

  • Hospital Verge del Toro

    Palma de Mallorca

  • Clínica Universitaria de Navarra

    Pamplona

  • Hospital de Navarra

    Pamplona

  • Hospital Virgen del Camino

    Pamplona

  • Complejo Hospitalario de Pontevedra_Hospital Montecelo

    Pontevedra

  • Complejo Hospitalario de Pontevedra_Hospital Provincial

    Pontevedra

  • Corporació Sanitaria Parc Taulí

    Sabadell

  • Hospital de Sagunto

    Sagunto

  • Hospital Clínico de Salamanca

    Salamanca

  • Hospital San Pedro de Alcántara

    San Pedro

  • Clínica Sant Camil

    Sant Pere de Ribes

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife

  • Hospital Universitario Marqués de Valdecilla

    Santander

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

  • Hospital General de Segovia

    Segovia

  • Hospital Joan XXIII

    Tarragona

  • Hospital Nuestra Señora del Prado

    Toledo

  • Hospital Virgen de la Salud

    Toledo

  • Fundación Instituto Valenciano de Oncología

    Valencia

  • Hospital Arnau de Vilanova

    Valencia

  • Hospital Clínico Universitario de Valencia

    Valencia

  • Hospital Francesc de Borja

    Valencia

  • Hospital General Básico de la Defensa

    Valencia

  • Hospital Universitario La Fe

    Valencia

  • Hospital Clínico Universitario de Valladolid

    Valladolid

  • Hospital Comarcal Pius de Valls

    Valls

  • Complejo Hospitalario Universitario de Vigo

    Vigo

  • Comarcal de Vinaros

    Vinaròs

  • Hospital Txagorritxu

    Vitoria-Gasteiz

  • Hospital de Galdakao

    Vizcaya

  • Hospital Virgen de la Concha

    Zamora

  • Hospital Royo Villanova

    Zaragoza, Aragon

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza

  • Hospital Miguel Servet

    Zaragoza

Other trials in Spain

About this study

Official title: A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With Melphalan/Prednisone/Velcade Versus Thalidomide / Prednisone / Velcade and Maintenance Treatment With Thalidomide / Velcade Versus Prednisone / Velcade in Untreated Patients With Multiple Myeloma More Than 65 Years Old.

The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments

Read the detailed description

A total of up to 260 patients > 65 years old diagnosed of Multiple Myeloma with symptomatic disease and that have not received previous chemotherapy for MM will be included.

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 randomized one to one to receive Melphalan+Prednisone+Velcade (Group A) or Thalidomide+Prednisone+Velcade (Group B). All of them will received the induction treatment up to 30 weeks. After 4 weeks, without progression and unacceptable toxicity, Patients will be again randomized one to one to receive maintenance treatment: Thalidomide+Velcade (Group M1) or Prednisone+Velcade (Group M2) during three years.

Once the treatment period has finished a follow up will be carry out. During this period we will evaluated response, progression-free survival and global survival every three months.

Being tested
Melphalan/Prednisone/Velcade, Thalidomide/Prednisone/Velcade
Keywords
Older patients, untreated patients
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Melphalan/Prednisone/VelcadeDrug

    One cycle:

    Melfalan, 9 mg/m2 v.o days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4 Velcade, 1,3 mg/m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Melfalán, 9 mg/m2 vo, days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4, Velcade,1,3 mg/ m2 iv (days 1, 8, 15 and 22)

  • Thalidomide/Prednisone/VelcadeDrug

    One cycle:

    Thalidomide,day 1 cycle 1 v.o (50 mg). If toxicity < grade 2, dose will be increased to 100 mg on day 15 cycle 1 Prednisona, 60 mg/m2 vo, days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32)

    Five cycles:

    Thalidomide, 100 mg vo all days, Prednisone, 60 mg/m2 vo days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 8, 15 and 22)

Study groups in NCT00443235
Study groupRoleWhat they receive
AActive comparatorOne cycle: Melfalan, 9 mg/m2 v.o days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4 Velcade, 1,3 mg/m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Melfalán, 9 mg/m2 vo, days 1 to 4 Prednisone, 60 mg/m2 v.o days 1 to 4, Velcade,1,3 mg/ m2 iv (days 1, 8, 15 and 22)
Receives: Drug: Melphalan/Prednisone/Velcade
BExperimentalOne cycle: Thalidomide,day 1 cycle 1 v.o (50 mg). If toxicity < grade 2, dose will be increased to 100 mg on day 15 cycle 1 Prednisona, 60 mg/m2 vo, days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 4, 8, 11, 22, 25, 29 and 32) Five cycles: Thalidomide, 100 mg vo all days, Prednisone, 60 mg/m2 vo days 1 to 4, Velcade, 1,3 mg/ m2 iv (days 1, 8, 15 and 22)
Receives: Drug: Thalidomide/Prednisone/Velcade

What is being measured

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

  1. The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments

    Measured: 5 years

Timeline

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

  1. First posted5 Mar 2007 (estimated)
  2. Study startMar 2005
  3. Primary completionMar 2007
  4. Study completionDec 2009

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
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00443235
Sponsor's protocol ID
2005-001111-21
Other IDs
2005
Status last verified
Sep 2011
First submitted
2 Mar 2007
Last updated
19 Sep 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7.

    PubMed 10735013

  • 2. Longo D. Plasma cell disorders. In : Fauce A, et al. Ed. Harrison's Principles of Internal Medicine. 14th Ed. New York, New York: Mc Graw-Hill; 1998: 712-718.

  • Raje N, Anderson K. Thalidomide--a revival story. N Engl J Med. 1999 Nov 18;341(21):1606-9. doi: 10.1056/NEJM199911183412110. No abstract available.

    PubMed 10564693

  • Holland JR, Hosley H, Scharlau C, Carbone PP, Frei E 3rd, Brindley CO, Hall TC, Shnider BI, Gold GL, Lasagna L, Owens AH Jr, Miller SP. A controlled trial of urethane treatment in multiple myeloma. Blood. 1966 Mar;27(3):328-42. No abstract available.

    PubMed 5933438

  • Alexanian R, Haut A, Khan AU, Lane M, McKelvey EM, Migliore PJ, Stuckey WJ Jr, Wilson HE. Treatment for multiple myeloma. Combination chemotherapy with different melphalan dose regimens. JAMA. 1969 Jun 2;208(9):1680-5. doi: 10.1001/jama.208.9.1680. No abstract available.

    PubMed 5818682

  • Salmon SE, Haut A, Bonnet JD, Amare M, Weick JK, Durie BG, Dixon DO. Alternating combination chemotherapy and levamisole improves survival in multiple myeloma: a Southwest Oncology Group Study. J Clin Oncol. 1983 Aug;1(8):453-61. doi: 10.1200/JCO.1983.1.8.453.

    PubMed 6366141

  • Boccadoro M, Marmont F, Tribalto M, Avvisati G, Andriani A, Barbui T, Cantonetti M, Carotenuto M, Comotti B, Dammacco F, et al. Multiple myeloma: VMCP/VBAP alternating combination chemotherapy is not superior to melphalan and prednisone even in high-risk patients. J Clin Oncol. 1991 Mar;9(3):444-8. doi: 10.1200/JCO.1991.9.3.444.

    PubMed 1999714

  • MacLennan IC, Chapman C, Dunn J, Kelly K. Combined chemotherapy with ABCM versus melphalan for treatment of myelomatosis. The Medical Research Council Working Party for Leukaemia in Adults. Lancet. 1992 Jan 25;339(8787):200-5. doi: 10.1016/0140-6736(92)90004-m.

    PubMed 1346171

  • Oken MM, Harrington DP, Abramson N, Kyle RA, Knospe W, Glick JH. Comparison of melphalan and prednisone with vincristine, carmustine, melphalan, cyclophosphamide, and prednisone in the treatment of multiple myeloma: results of Eastern Cooperative Oncology Group Study E2479. Cancer. 1997 Apr 15;79(8):1561-7.

    PubMed 9118039

  • Blade J, San Miguel JF, Alcala A, Maldonado J, Sanz MA, Garcia-Conde J, Moro MJ, Alonso C, Besalduch J, Zubizarreta A, et al. Alternating combination VCMP/VBAP chemotherapy versus melphalan/prednisone in the treatment of multiple myeloma: a randomized multicentric study of 487 patients. J Clin Oncol. 1993 Jun;11(6):1165-71. doi: 10.1200/JCO.1993.11.6.1165.

    PubMed 8501503

  • Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.

    PubMed 9850028

  • Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin D, Rajkumar SV, Srkalovic G, Alsina M, Alexanian R, Siegel D, Orlowski RZ, Kuter D, Limentani SA, Lee S, Hideshima T, Esseltine DL, Kauffman M, Adams J, Schenkein DP, Anderson KC. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med. 2003 Jun 26;348(26):2609-17. doi: 10.1056/NEJMoa030288.

    PubMed 12826635

  • Jagannath S, Barlogie B, Berenson J, Siegel D, Irwin D, Richardson PG, Niesvizky R, Alexanian R, Limentani SA, Alsina M, Adams J, Kauffman M, Esseltine DL, Schenkein DP, Anderson KC. A phase 2 study of two doses of bortezomib in relapsed or refractory myeloma. Br J Haematol. 2004 Oct;127(2):165-72. doi: 10.1111/j.1365-2141.2004.05188.x.

    PubMed 15461622

  • 14. Paul Richardson et al. Bortezomib Demonstrates Superior Efficacy to High-Dose Dexamethasone in Relapsed Multiple Myeloma: Final Report of the APEX Study. Blood 2004; 104(11):Abstract number 336.5

  • Rajkumar SV, Hayman S, Gertz MA, Dispenzieri A, Lacy MQ, Greipp PR, Geyer S, Iturria N, Fonseca R, Lust JA, Kyle RA, Witzig TE. Combination therapy with thalidomide plus dexamethasone for newly diagnosed myeloma. J Clin Oncol. 2002 Nov 1;20(21):4319-23. doi: 10.1200/JCO.2002.02.116.

    PubMed 12409330

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Melphalan/Prednisone/Velcade and Thalidomide/Prednisone/Velcade in people with Multiple Myeloma, run by PETHEMA Foundation at 77 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 11 inclusion and 9 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 19 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 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 analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments (time frame: 5 years). 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 NCT00443235, which also lists 43 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 19 Sep 2011.

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