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Multiple MyelomaPhase 3GEM05MENOS65NCT00461747

GEM05 for Patients With Multiple Myeloma Under 65 Years

A Phase 3 study testing VBMCP/VBAD/Velcade, Thalidomide/Dexamethasone and Velcade/Thalidomide/Dexamethasone in people with Multiple Myeloma, run by PETHEMA Foundation at 79 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 compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone. The second one is to evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Read more about this study

Who is it for?
Ages Up to 65 years
Conditions the study is for
Multiple Myeloma
What is being tested?
VBMCP/VBAD/Velcade, Thalidomide/Dexamethasone and Velcade/Thalidomide/Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
390 participants
Where
79 sitesSpain
Study dates
Mar 2006to Dec 2008
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 Up to 65 years
  • All sexes
  • No healthy volunteers
  • Child, 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 <65 years and possibly to do an autologous transplant.
  • Patient recently diagnosed with symptomatic Multiple Myeloma who has not received any previous chemotherapy treatment for Multiple Myeloma.
  • Patient has a measurable disease defined as quantifiable serum monoclonal protein value and, where applicable, urine Light-chain excretion of ≥ 200 mg/24 hours.
  • ECOG < 2.
Show all 15Show fewer
  • El 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.
  • For Patients included in Thalidomide branches: women of childbearing age must not have sex unless they use two anticonceptive methods beginning 4 weeks before the first dose, during all the study until 4 weeks after the last one.

Who cannot join

  • Non-secretor Myeloma.
  • Patients previously received treatment to Multiple Myeloma, except steroids doses for urgency or bisphosphonates or radiotherapy before beginning treatment.
  • 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 or Thalidomide.
  • Patient has received other investigational drugs within 30 days before enrolment.
Show all 10Show 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.
  • Pregnancy or breast-feed women.

Trial locations and contacts

79 sites in 1 country.

79 sites in 1 country

Spain79 sites

  • Complejo Hospitalario Universitario de Albacete

    Albacete

  • Fundación Hospital Alcorcón

    Alcorcón

  • Hospital General de Alicante

    Alicante, Alicante

  • Hospital Ntra. Sra. Sonsoles

    Ávila, Avila

  • 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

  • Basurtuko Ospitalea

    Bilbao

  • Hospital de Cruces

    Bilbao

  • Hospital Virgen del Puerto

    Cáceres

  • Hospital general de Castellón

    Castelló, Castellón

  • 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

  • Hospital General de Guadalajara

    Guadalajara

  • Hospital de San Jorge

    Huesca

  • Hospital General de Lanzarote

    Lanzarote

  • Complejo Hospitalario León

    León

  • Complexo Hospitalario Xeral-Calde

    Lugo

  • Hospital Clínico San Carlos de Madrid

    Madrid, Madrid

  • Hospital Universitario de la Princesa

    Madrid, Madrid

  • Clínica Moncloa

    Madrid

  • Clínica Puerta de Hierro

    Madrid

  • Clínica Rúber

    Madrid

  • Fundación Jiménez Díaz

    Madrid

  • Hospital 12 de Octubre

    Madrid

  • Hospital Central de la Defensa

    Madrid

  • Hospital Ramón y Cajal

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Xarxa assistencial de Manresa

    Manresa, Barcelona

  • Fundación Hospital Sant Joan de Déu de Martorell

    Martorell

  • Hospital de Mérida

    Mérida

  • Hospital General Morales Meseguer

    Murcia

  • Hospital Santa María del Rosell

    Murcia

  • Hospital Virgen del Castillo de Yecla

    Murcia

  • Hospital Central de Asturias

    Oviedo, Oviedo

  • Hospital del Río Carrión

    Palencia, Palencia

  • 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, Navarre

  • Hospital de Navarra

    Pamplona

  • Hospital Virgen del Camino

    Pamplona

  • Complejo Hospitalario de Pontevedra_Hospital Montecelo

    Pontevedra

  • Complejo Hospitalario de Pontevedra_Hospital Provincial

    Pontevedra

  • Corporació Sanitària Parc Taulí

    Sabadell, Barcelona

  • 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, Tarragona

  • Hospital Nuestra Señora del Prado

    Toledo

  • Hospital Virgen de la Salud

    Toledo

  • Hospital Clínic

    Valencia, Valencia

  • Hospital La Fe

    Valencia, Valencia

  • Fundación Instituto Valenciano de Oncología

    Valencia

  • Hospital Arnau de Vilanova

    Valencia

  • Hospital Dr. Peset

    Valencia

  • Hospital Francesc de Borja

    Valencia

  • Hospital General Básico de la Defensa

    Valencia

  • Hospital Clínico de Valladolid

    Valladolid

  • 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 Lozano Blesa

    Zaragoza, 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 VBMCP-VBAD/Velcade Versus Thalidomide / Dexamethasone Versus Velcade / Thalidomide / Dexamethasone Followed by High Dose Intensive Therapy With Autologous Hemopoietic Stem Cell Support and Maintenance Treatment With Interferon-a Versus Thalidomide Versus Thalidomide / Velcade in Untreated Patients With Multiple Myeloma Less Than 65 Yrs Old

The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone. The second one is to evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Otherwise this study wants to compare the safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide versus Thalidomide/Velcade.

Read the detailed description

A total of up to 390 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 (1:1:1) to receive VBMCP-VBAD+Velcade (Group A) or Thalidomide+Dexamethasone (Group B) or Thalidomide+Dexamethasone+Velcade (Group C). All of them will received the induction treatment up to 24 weeks.

After 4 weeks, without progression or unacceptable toxicity, There will be stem cell mobilization to do an autologous transplant. Three months after transplant, patients will be again randomized (1:1:1) to receive maintenance treatment: Interferon-a (Group M1) or Thalidomide (Group M2) or Thalidomide+Velcade (Group M3) 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
VBMCP/VBAD/Velcade, Thalidomide/Dexamethasone, Velcade/Thalidomide/Dexamethasone
Keywords
Untreated, Transplant, Younger
Medical subject headings
Multiple Myeloma

What participants receive

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

  • VBMCP/VBAD/VelcadeDrug

    VBMCP: Vincristine, 0,03 mg/Kg (iv) day 1, BCNU, 0,5 mg/Kg iv day 1, Cyclophosphamide, 10 mg/Kg iv day 1, Melfalan, 0,25 mg/Kg oral days 1 to 4 Prednisone, 1 mg/Kg oral days 1 to 4; 0,5 mg/Kg oral days 5 to 8 and 0,25 mg/Kg oral days 9 to 12.

    VBAD : Vincristine, 1mg via iv day 1, BCNU, 30 mg/m2 iv day 1, Adriamycine, 40mg/m2 iv day 1 Dexamethasone, 40 mg oral days 1 to 4, 9 to 12 and 17 to 20.

  • Thalidomide/DexamethasoneDrug

    Thalidomide day 1, cycle 1 (50 mg/day v.o). If toxicity < grade 2, dose will be 100 mg/day on day 15, cycle 1 and 200 mg/day on day 1, cycle 2.

    Dexamethasone:40 mg/day v.o.days 1 to 4 and 9 to 12, with a period without treatment of 16 days

  • Velcade/Thalidomide/DexamethasoneDrug

    Thalidomide: day 1 cycle 1 (50 mg/day).If toxicity is < grade 2, the dose increased (100 mg/day) at day 15 cycle 1 and (200 mg de Thalidomide) at day 1 cycle 2.

    Dexamethasone: 40 mg/day v.o days 1 to 4 and 8 to 11, with a period without treatment of 17 days.

    Velcade: 1,3 mg/m2 iv twice a week (days 1, 4, 8 and 11) with a period without treatment of 17 days

Study groups in NCT00461747
Study groupRoleWhat they receive
AActive comparatorFour alternating cycles of VBMCP/VBAD + Velcade VBMCP: Vincristine, 0,03 mg/Kg (iv) day 1, BCNU, 0,5 mg/Kg iv day 1, Cyclophosphamide, 10 mg/Kg iv day 1, Melfalán, 0,25 mg/Kg oral days 1 to 4 Prednisone, 1 mg/Kg oral days 1 to 4; 0,5 mg/Kg oral days 5 to 8 and 0,25 mg/Kg oral days 9 to 12. VBAD : Vincristine, 1mg via iv day 1, BCNU, 30 mg/m2 iv day 1, Adriamycine, 40mg/m2 iv day 1 Dexamethasone, 40 mg oral days 1 to 4, 9 to 12 and 17 to 20. The interval between VBMCP and VBAD is 5 weeks and between VBAD and VBMCP is 4 weeks. The patients will received two cycles of VBMCP and two cycles of VBAD. After 4 weeks of last cycle of VBAD, patients will received two cycles of Velcade, 1,3 mg/ m2 iv twice a week (days 1, 4, 8 and 11), followed by 10 days without treatment
Receives: Drug: VBMCP/VBAD/Velcade
BExperimentalSix cycles of 4 weeks of Thalidomide/Dexamethasone. Thalidomide day 1, cycle 1 (50 mg/day v.o). If toxicity < grade 2, dose will be 100 mg/day on day 15, cycle 1 and 200 mg/day on day 1, cycle 2. Dexamethasone:40 mg/day v.o.days 1 to 4 and 9 to 12, with a period without treatment of 16 days
Receives: Drug: Thalidomide/Dexamethasone
CExperimentalThalidomide: day 1 cycle 1 (50 mg/day).If toxicity is < grade 2, the dose will be increased (100 mg/day) at day 15 cycle 1 and (200 mg de Thalidomide) at day 1 cycle 2. Dexamethasone: 40 mg/day v.o days 1 to 4 and 8 to 11, with a period without treatment of 17 days. Velcade: 1,3 mg/m2 iv twice a week (days 1, 4, 8 and 11) with a period without treatment of 17 days.
Receives: Drug: Velcade/Thalidomide/Dexamethasone

What is being measured

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

  1. The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone.

    Measured: 2 years

Secondary outcomes (1)

  1. Evaluate the ability of stem cell mobilization after the treatments in order to do an autologous transplant. Otherwise this study wants to compare the safety and efficacy of the maintenance treatments: Interferón a-2b versus Thalidomide

    Measured: 2 years

Timeline

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

  1. First posted18 Apr 2007 (estimated)
  2. Study startMar 2006
  3. Primary completionDec 2008
  4. Study completionDec 2008

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
390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00461747
Sponsor's protocol ID
2005-001110-41
Other IDs
2005
Acronym
GEM05MENOS65
Status last verified
Sep 2009
First submitted
17 Apr 2007
Last updated
18 Sep 2009
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

  • Oken MM. Management of Myeloma: Current and Future Approaches. Cancer Control. 1998 May;5(3):218-225. doi: 10.1177/107327489800500302.

    PubMed 10761055

  • 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

  • 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

  • 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

  • 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

  • Gore ME, Selby PJ, Viner C, Clark PI, Meldrum M, Millar B, Bell J, Maitland JA, Milan S, Judson IR, et al. Intensive treatment of multiple myeloma and criteria for complete remission. Lancet. 1989 Oct 14;2(8668):879-82. doi: 10.1016/s0140-6736(89)91548-1.

    PubMed 2571812

  • Samson D, Gaminara E, Newland A, Van de Pette J, Kearney J, McCarthy D, Joyner M, Aston L, Mitchell T, Hamon M, et al. Infusion of vincristine and doxorubicin with oral dexamethasone as first-line therapy for multiple myeloma. Lancet. 1989 Oct 14;2(8668):882-5. doi: 10.1016/s0140-6736(89)91549-3.

    PubMed 2571813

  • Hjorth M, Holmberg E, Rodjer S, Turesson I, Westin J, Wisloff F. Survival in conventionally treated younger (<60 years) multiple myeloma patients: no improvement during two decades. Nordic Myeloma Study Group (NMSG). Eur J Haematol. 1999 Apr;62(4):271-7. doi: 10.1111/j.1600-0609.1999.tb01757.x.

    PubMed 10227461

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VBMCP/VBAD/Velcade, Thalidomide/Dexamethasone and Velcade/Thalidomide/Dexamethasone in people with Multiple Myeloma, run by PETHEMA Foundation at 79 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 15 inclusion and 10 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 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 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 compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone. (time frame: 2 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 NCT00461747, which also lists 57 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 18 Sep 2009.

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