AzTrials
AzTrials

Multiple MyelomaPhase 2NCT01237249

Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 65 Years With Sequential Melphalan/Prednisone/Velcade (MPV) Followed by Revlimid/Low Dose Dexamethasone (Rd) Versus Alternating Velcade/Melphalan/Prednisone (MPV) With Revlimid/Low Dose Dexamethasone

A Phase 2 study testing Melphalan, Prednisone and Velcade in people with Multiple Myeloma, run by PETHEMA Foundation at 63 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

This is a national, multicenter, open-label, randomized, comparative study designed to compare, first, the TTP of the two treatment schemes proposed (MPV followed by Rd or MPV alternating with Rd) in newly diagnosed MM patients older than 65 years. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Melphalan, Prednisone and Velcade
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
63 sitesSpain
Study dates
Feb 2011to May 2016
Phase
Phase 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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Written informed consent obtained before starting any study-specific procedure.
  • Symptomatic elderly MM newly diagnosed by EBMT criteria older than 65 years.
  • Performance status (ECOG) ≤ 2.
  • Have pre-treatment clinical laboratory values meeting the following criteria within 14 days of randomization:
  • platelet count ≥ 75x109/L
  • haemoglobin ≥ 8g/dL
Show all 9Show fewer
  • absolute neutrophil count (ANC) ≥ 1.0x109/L
  • Serum bilirubin ≤ 1.5 mg/dL and alkaline phosphatise ≤ 2.5 x ULN AST, ALT ≤ 2.5 x ULN
  • Serum creatinine ≤2,5 mg/dl

Who cannot join

  • Patient previously received treatment with Velcade or Revlimid.
  • Patient previously received treatment for Multiple Myeloma.
  • Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrolment.
  • Patient has hypersensitivity to bortezomib, boron, mannitol or lenalidomide.
  • Patient has received other investigational drugs with 28 days before enrolment.
  • Patient had a myocardial infarction within 6 months of enrolment 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 currently is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.
  • Radiation therapy within 30 days before randomization, at least patient has had antialgic radiation. Radiation therapy will be afterwards permitted during the treatment period if it is indicated due to the presence of plasmacytomas

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

Spain63 sites

  • Hospital Principe de Asturias

    Alcalá de Henares, Madrid

  • Fundación Hospital Alcorcón

    Alcorcón

  • Hospital de Badalona Germans Trias i Pujol

    Badalona

  • H. Vall d'Hebron, Barcelona

    Barcelona, Barcelona

  • ICO - Duran i Reynals, Hospitalet de Llobregat

    Barcelona, Barcelona

  • Hospital Clinic i Provincial de Barcelona

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital de Cruces

    Bilbao

  • Complejo Hospitalario de Cáceres

    Cáceres

  • Hospital Puerta del Mar

    Cadiz

  • Hospital General de Castellón

    Castellon, Castellón

  • Hospital General

    Ciudad Real

  • Hospital Virgen de la Luz

    Cuenca

  • Hospital Donostia

    Donostia / San Sebastian

  • Hospital Francesc Borja

    Gandia

  • ICO - Josep Trueta

    Girona

  • Hospital General de Guadalajara

    Guadalajara

  • H. de Jerez

    Jerez de la Frontera

  • Complejo Hospitalario León

    León

  • Hospital Ramón y Cajal

    Madrid, Madrid

  • Clínica Puerta de Hierro

    Madrid

  • Hospital 12 de Octubre. Madrid

    Madrid

  • Hospital Clinico San Carlos

    Madrid

  • Hospital de Fuenlabrada

    Madrid

  • Hospital de la Princesa

    Madrid

  • Hospital de Madrid, S.A.- Norte Hospital General

    Madrid

  • Hospital del Tajo

    Madrid

  • Hospital Infanta Leonor

    Madrid

  • Hospital Infanta Sofia

    Madrid

  • Hospital la Paz

    Madrid

  • Hospital Severo Ochoa

    Madrid

  • Hospital Universitario Gregorio Marañón

    Madrid

  • MD Anderson

    Madrid

  • Complejo Hospital Costa del Sol

    Málaga

  • Hospital Nuestra Señora de Valme

    Málaga

  • Althaia

    Manresa

  • Hospital General Univeristario Morales Messeguer

    Murcia

  • Hospital Virgen de la Arrixaca

    Murcia

  • Hospital de la Diputación de Navarra

    Navarra

  • Hospital de Gran Canaria Doctor Negrín

    Palma de Gran Canaria

  • H. Son Llatzer

    Palma de Mallorca, Balearic Islands

  • Complejo Asistencial Son Dureta

    Palma de Mallorca

  • Clínica Universitaria de Navarra

    Pamplona, Navarre

  • Hospital Virgen del Camino

    Pamplona

  • Corporació Sanitaria Parc Taulí

    Sabadell

  • Hospital Clínico de Salamanca

    Salamanca

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife

  • Hoaspital Marqués de Valdecilla

    Santander

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

  • Hospital General de Segovia

    Segovia

  • Complejo Hospitalario Regional Virgen del Rocío

    Seville

  • Hospital Joan XXIII

    Tarragona, Tarragona

  • Hospital Nuestra Señora del Prado

    Toledo

  • Hospital Virgen de la Salud

    Toledo

  • Hospital Universitario Dr. Peset

    Valencia, Valencia

  • Hospital Arnau de Vilanova

    Valencia

  • Hospital Clínico de Valencia.

    Valencia

  • Hospital La Fe

    Valencia

  • Hospital Txagorritxu

    Vitoria-Gasteiz

  • Hospital Virgen de la Concha

    Zamora

  • Miguel Servet

    Zaragoza, Zaragoza

  • Hospital Clinico Lozano Blesa

    Zaragoza

Other trials in Spain

About this study

Official title: A National, Open-label, Multicenter, Randomized, Comparative Phase IIb Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 65 Years With Sequential Melphalan/Prednisone/Velcade (MPV) Followed by Revlimid/Low Dose Dexamethasone (Rd) Versus Alternating Velcade/Melphalan/Prednisone (MPV) With Revlimid/Low Dose Dexamethasone (Rd).

This is a national, multicenter, open-label, randomized, comparative study designed to compare, first, the TTP of the two treatment schemes proposed (MPV followed by Rd or MPV alternating with Rd) in newly diagnosed MM patients older than 65 years. This comparison will be performing in terms of both efficacy and safety. Up to 120 patients will be included in each treatment arm and evaluated at scheduled visits in up to 3 study periods: Pre-treatment, Treatment and Follow-up.

Primary outcome measure:

Read more
  • To evaluate the efficacy in terms of time to progression (TTP) at 18 months of MPV and Rd used as either in a sequential or alternating approach in newly diagnosed MM patients older than 65 years.
  • To evaluate the toxicity (safety and tolerability) of the sequential versus the alternating use of MPV and Rd.

Secondary outcome measure:

  • To evaluate the response, duration of response, progression free survival (PFS), time to next therapy (TNT) and overall survival (OS) in the two different groups of patients.
  • To identify, within the group of patients treated with the alternating scheme, the biological characteristics (including a comprehensive genomic analysis) of those patients resistant to one or the other, and patients refractory to both treatments
Read the detailed description

The Pre-treatment period includes Screening visit. After providing written informed consent form to participate in the study, patients will be evaluated for eligibility during a screening period of 14 days (Days -14 to -1). If patients meet all inclusion and exclusion criteria will be randomized at the moment of entry in the trial in a 1:1 allocation to receive either MPV followed by Rd (Treatment Group A) or MPV alternating with Rd (Treatment Group B).

Patients in the Treatment Group A will receive nine cycles of MPV consisting on one 6-weeks cycle of Velcade (Bortezomib) as an intravenous bolus twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32) followed by a 10 day rest period (day 33 to 42), in combination with oral Melphalan, once daily on days 1 to 4 and oral Prednisone, once daily on days 1 to 4, followed by eight 4-weeks cycles of Velcade (Bortezomib) as an intravenous bolus on days 1, 8, 15 and 22 followed by a 6 day rest period (days 23 to 28), in combination with Melphalan and Prednisone per os once daily on days 1 to 4, followed by a 24-day rest period (days 5 to 28). After the nine MPV cycles, patients will receive nine cycles of Rd consisting on 4-weeks cycles, including Revlimid (lenalidomide), once daily on days 1-21 followed by a 7 day rest period (days 22 to 28) plus oral dexamethasone, once weekly on days 1,8,15 and 22, followed by a 6 day rest period (days 23 to 28).

Patients in the Treatment Group B will receive the same schedule of therapy, but the MPV cycles will be alternated with Rd cycles. In this treatment Group B, patients will be again randomized to start receiving either MPV or Rd as first cycle of therapy. Overall, patients will receive an identical number of cycles, nine cycles of MPV and nine of Rd. Patients randomized to Treatment Group A relapsing/progressing or with major toxicities under treatment with MPV will be crossover to receive Rd, but only after study coordinator approval.

During the Treatment Period, patients will be evaluated at day 1 of each cycle. After completion of the Treatment Period, all patients will be evaluated every 2 months thereafter.

Safety will be assessed by the monitoring of adverse events, physical examinations, vital signs measurements, and haematology and clinical chemistry test. Response to treatment will be based on EBMT an IMWG criteria. Response to treatment will be evaluated at day 1 of each induction cycle, and every 2 months during thereafter.

Being tested
Melphalan, Prednisone, Velcade, Revlimid, Dexamethasone
Keywords
Multiple Myeloma, Velcade, Revlimid
Medical subject headings
Multiple Myeloma

What participants receive

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

Study groups in NCT01237249
Study groupRoleWhat they receive
MPV followed by Revlimid/Low Dose Dexamethasone (Rd)Active comparatorMelphalan/Prednisone/Velcade (MPV) followed by Revlimid/Low Dose Dexamethasone (Rd)
Receives: Drug: Melphalan; Drug: Prednisone; Drug: Velcade
Alternating MPV with Revlimid/Low Dose DexamethasoneExperimentalAlternating Velcade/Melphalan/Prednisone (MPV) with Revlimid/Low Dose Dexamethasone (Rd)
Receives: Drug: Revlimid; Drug: Dexamethasone

What is being measured

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

  1. To evaluate the efficacy in terms of time to progression (TTP) at 18 months of MPV and Rd used as either in a sequential or alternating approach in newly diagnosed MM patients older than 65 years.

    Measured: 18 months

  2. To evaluate the toxicity (safety and tolerability) of the sequential versus the alternating use of MPV and Rd,in terms of adverse events presented in both groups of patients

    Measured: 6 months

Secondary outcomes (6)

  1. To evaluate the response in both groups of patients

    Measured: 1 year

  2. To identify, within the group of patients treated with the alternating scheme, the biological characteristics (including a comprehensive genomic analysis) of those patients resistant to one or the other, and patients refractory to both treatments

    Measured: 2 years

  3. Duration of response in two groups of patients

    Measured: 2 years

  4. Progression free survival (PFS) in two different groups of patients

    Measured: 18 months

  5. Time to next therapy (TNT)

    Measured: 2 years

  6. Overall survival (OS) in the two different groups of patients

    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 posted9 Nov 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionAug 2014
  4. Study completionMay 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01237249
Sponsor's protocol ID
GEM2010MAS65
Status last verified
Jan 2017
First submitted
4 Nov 2010
Last updated
18 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Quwaider D, Corchete LA, Misiewicz-Krzeminska I, Sarasquete ME, Perez JJ, Krzeminski P, Puig N, Mateos MV, Garcia-Sanz R, Herrero AB, Gutierrez NC. DEPTOR maintains plasma cell differentiation and favorably affects prognosis in multiple myeloma. J Hematol Oncol. 2017 Apr 18;10(1):92. doi: 10.1186/s13045-017-0461-8.

    PubMed 28420429

  • Paiva B, Cedena MT, Puig N, Arana P, Vidriales MB, Cordon L, Flores-Montero J, Gutierrez NC, Martin-Ramos ML, Martinez-Lopez J, Ocio EM, Hernandez MT, Teruel AI, Rosinol L, Echeveste MA, Martinez R, Gironella M, Oriol A, Cabrera C, Martin J, Bargay J, Encinas C, Gonzalez Y, Van Dongen JJ, Orfao A, Blade J, Mateos MV, Lahuerta JJ, San Miguel JF; Grupo Espanol de Mieloma/Programa para el Estudio de la Terapeutica en Hemopatias Malignas (GEM/PETHEMA) Cooperative Study Groups. Minimal residual disease monitoring and immune profiling in multiple myeloma in elderly patients. Blood. 2016 Jun 23;127(25):3165-74. doi: 10.1182/blood-2016-03-705319. Epub 2016 Apr 26.

    PubMed 27118453

  • Paiva B, Corchete LA, Vidriales MB, Puig N, Maiso P, Rodriguez I, Alignani D, Burgos L, Sanchez ML, Barcena P, Echeveste MA, Hernandez MT, Garcia-Sanz R, Ocio EM, Oriol A, Gironella M, Palomera L, De Arriba F, Gonzalez Y, Johnson SK, Epstein J, Barlogie B, Lahuerta JJ, Blade J, Orfao A, Mateos MV, San Miguel JF; Spanish Myeloma Group / Program for the Study of Malignant Blood Diseases Therapeutics (GEM / PETHEMA) Cooperative Study Groups. Phenotypic and genomic analysis of multiple myeloma minimal residual disease tumor cells: a new model to understand chemoresistance. Blood. 2016 Apr 14;127(15):1896-906. doi: 10.1182/blood-2015-08-665679. Epub 2016 Jan 11.

    PubMed 26755711

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Melphalan, Prednisone and Velcade in people with Multiple Myeloma, run by PETHEMA Foundation at 63 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 9 inclusion and 8 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 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 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 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?

To evaluate the efficacy in terms of time to progression (TTP) at 18 months of MPV and Rd used as either in a sequential or alternating approach in newly diagnosed MM patients older than 65 years. (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT01237249, which also lists 3 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 Jan 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in