Multiple MyelomaPhase 1/2NCT00388635

Velcade-Melphalan-Prednisone in Older Untreated Multiple Myeloma Patients.

A Phase 1/2 study testing Velcade, Melphalan and Prednisone in people with Multiple Myeloma, run by PETHEMA Foundation at 19 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

Who is it for?: Ages 65 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Velcade, Melphalan and Prednisone
How many people: 60 participants
Where: 19 sitesSpain
Study dates: Apr 2004to Dec 2008
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Age over 65 years.
Patient recently diagnosed with symptomatic Multiple Myeloma based on standard criteria and that has not received any previous chemotherapy treatment for Multiple Myeloma.
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 12Show fewer

For oligo or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with oligo-secretory multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessment. In patients with non-secretory multiple myeloma, there is no M-protein in serum or urine.
Patient has a Karnofsky performance status higher 60%.
Patient has a life-expectancy >3 months.
Patient has the following laboratory values within 14 days before Baseline visit (Day 1 of Cycle 1, before study drug administration:
Platelet count ≥ 100x109/L, hemoglobin ≥ 8 g/dl and absolute neutrophil count (ANC) ≥ 1.0x109/L.
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 value ≤ 2mg/dl.

Who cannot join

Patient previously received treatment with Velcade.
Patient previously received treatment for Multiple Myeloma.
Patient had major surgery within 4 weeks before enrollment.
Patient has a platelet count < 100 x 109/L within 14 days before enrollment.
Patient has an absolute neutrophil count < 1.0 x 109/L within 14 days before.
Patient has < Grade 2 peripheral neuropathy within 14 days before enrollment.

Show all 11Show fewer

Patient has hypersensitivity to bortezomib, boron or mannitol.
Patient has received other investigational drugs within 14 days before enrollment.
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

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

Spain19 sites

Hospital Clínic
Barcelona, Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona
Hospital Germans Trias i Pujol
Barcelona, Barcelona
Hospital Virgen Blanca de León
León
Hospital Clínico San Carlos de Madrid
Madrid, Madrid
Hospital Doce de Octubre
Madrid, Madrid
Hospital Ramón y Cajal
Madrid, Madrid
Hospital Universitario de la Princesa
Madrid, Madrid
Hospital Morales Messeguer
Murcia, Murcia
Hospital Central de Asturias
Oviedo, Principality of Asturias
Hospital Son Llatzer
Palma de Mallorca, Mallorca
Clínica Universitaria de Navarra
Pamplona, Navarre
Hospital Clínico Universitario de Salamanca
Salamanca
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands
Hospital General de Segovia
Segovia
Hospital Clínic
Valencia, Valencia
Hospital La Fe
Valencia, Valencia
Hospital Universitario Dr. Peset
Valencia, Valencia
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza

Other trials in Spain

About this study

Official title: A National, Multi-Center, Open-Label Study of Velcade in Combination With Melphalan and Prednisone (V-MP) in Older Untreated Multiple Myeloma Patients.

This protocol is planned as a multicentric, national, open-label trial designed to evaluate, first, optimal dose of Velcade® (Bortezomib) in combination with melphalan and prednisone. After optimal dose is known, the second aim is evaluate safety and tolerance of V-MP plan, in respond terms, in a cohort of 60 patients. Finally, the entire results will be compared with those obtained from a series of 100 patients, all of them over 70 years old, diagnosed of Multiple Myeloma belonging to the GEM protocol finished in May 2003

Read the detailed description

Multiple Myeloma is a neoplastic disorder of the last maturation stage of B cell, called plasmatic cell. It represents the second most common haematological neoplasia, after Non Hodgkin Lymphoma. The annual incidence is over 4 cases per 100.000. Multiple Myeloma is an invariably mortal disease. When illness advances, the reduction of infections resistance, the intense bones destruction (with bone pain, pathological fractures and hypercalcemia), anaemia, renal failure and, in a less frequency, neurological complications and hyperviscosity provoke severe morbidity and mortality. Five-year survival rate in patients with Multiple Myeloma treated with conventional chemotherapy is 29%. There is an urgent need of new therapeutic agents for the treatment of this disease

Conditions: Multiple Myeloma
Being tested: Velcade, Melphalan, Prednisone
Keywords: Multiple Myeloma, Patients over 65 years old
Medical subject headings: Multiple Myeloma

What participants receive

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

VelcadeDrug
Phase I: Velcade, 1.0mg/m2-1.3mg/m2 in escalating doses every 6 weeks for 4 cycles Pase II: Velcade at optimal doses, twice a week (days 1, 4, 8, 11, 22, 25, 28 and 32) follow a rest period for 10 days (days 33 to 42)
MelphalanDrug
Melfalán 9mg/m2 days 1 to 4, V.O, follow by a rest period of 38 days in phse I and II
PrednisoneDrug
Prednisone 60mg/m2 v.o days 1 to 4 follows by a rest period of 38 days (phase I and II)

What is being measured

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

Determinate the efficacy of combination velcade, melphalan, prednisone
Measured: 1 year

Secondary outcomes (3)

Assess safety and tolerability
Measured: 1 year
Assess potential superiority of this regimen versus historical controls with melphalan and prednisone alone
Measured: 2 years
Evaluate efficacy in terms of progression-free survival and overall survival
Measured: 5 years

Timeline

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

Apr 2004Dec 2008

First posted17 Oct 2006 (estimated)
Study startApr 2004
Primary completionJan 2007
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00388635
Sponsor's protocol ID: PET-VEL-2004-01
Status last verified: Jan 2011
First submitted: 16 Oct 2006
Last updated: 11 Jan 2011
Results posted: No

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
Westin J. Conventional chemotherapy in multiple myeloma. Pathol Biol (Paris). 1999 Feb;47(2):169-71.
PubMed 10192883
Huang YW, Hamilton A, Arnuk OJ, Chaftari P, Chemaly R. Current drug therapy for multiple myeloma. Drugs. 1999 Apr;57(4):485-506. doi: 10.2165/00003495-199957040-00004.
PubMed 10235689
Smith ML, Newland AC. Treatment of myeloma. QJM. 1999 Jan;92(1):11-4. doi: 10.1093/qjmed/92.1.11.
PubMed 10209667
Bataille R, Harousseau JL. Multiple myeloma. N Engl J Med. 1997 Jun 5;336(23):1657-64. doi: 10.1056/NEJM199706053362307. No abstract available.
PubMed 9171069
Alexanian R, Dimopoulos M. The treatment of multiple myeloma. N Engl J Med. 1994 Feb 17;330(7):484-9. doi: 10.1056/NEJM199402173300709. No abstract available.
PubMed 8289856
Gregory WM, Richards MA, Malpas JS. Combination chemotherapy versus melphalan and prednisolone in the treatment of multiple myeloma: an overview of published trials. J Clin Oncol. 1992 Feb;10(2):334-42. doi: 10.1200/JCO.1992.10.2.334.
PubMed 1531068
Alexanian R, Barlogie B, Tucker S. VAD-based regimens as primary treatment for multiple myeloma. Am J Hematol. 1990 Feb;33(2):86-9. doi: 10.1002/ajh.2830330203.
PubMed 2301376
Alexanian R, Dimopoulos MA, Delasalle K, Barlogie B. Primary dexamethasone treatment of multiple myeloma. Blood. 1992 Aug 15;80(4):887-90.
PubMed 1498331
Case DC Jr, Lee DJ 3rd, Clarkson BD. Improved survival times in multiple myeloma treated with melphalan, prednisone, cyclophosphamide, vincristine and BCNU: M-2 protocol. Am J Med. 1977 Dec;63(6):897-903. doi: 10.1016/0002-9343(77)90543-5. No abstract available.
PubMed 605911
Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.
PubMed 8649495
Driscoll J. The role of the proteasome in cellular protein degradation. Histol Histopathol. 1994 Jan;9(1):197-202.
PubMed 8003815

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A National, Multi-Center, Open-Label Study of Velcade in Combination With Melphalan and Prednisone (V-MP) in Older Untreated Multiple Myeloma Patients.
ClinicalTrials.gov ID: NCT00388635
Acronym / sponsor ID: PET-VEL-2004-01
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma, Patients over 65 years old
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: PETHEMA FoundationUniversity, hospital or other
Collaborators: Millennium Pharmaceuticals, Inc., Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study start: Apr 2004
Primary completion: Jan 2007 (actual)
Study completion: Dec 2008 (actual)
First posted: 17 Oct 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (12 listed)

Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Age over 65 years.
Patient recently diagnosed with symptomatic Multiple Myeloma based on standard criteria and that has not received any previous chemotherapy treatment for Multiple Myeloma.
Patient has measurable disease, defined as follows:

Key exclusion criteria (11 listed)

Patient previously received treatment with Velcade.
Patient previously received treatment for Multiple Myeloma.
Patient had major surgery within 4 weeks before enrollment.
Patient has a platelet count < 100 x 109/L within 14 days before enrollment.
Patient has an absolute neutrophil count < 1.0 x 109/L within 14 days before.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VelcadePhase I: Velcade, 1.0mg/m2-1.3mg/m2 in escalating doses every 6 weeks for 4 cycles Pase II: Velcade at optimal doses, twice a week (days 1, 4, 8, 11, 22, 25, 28 and 32) follow a rest period for 10 days (days 33 to 42)	Drug	–
MelphalanMelfalán 9mg/m2 days 1 to 4, V.O, follow by a rest period of 38 days in phse I and II	Drug	–
PrednisonePrednisone 60mg/m2 v.o days 1 to 4 follows by a rest period of 38 days (phase I and II)	Drug	–

Primary outcome

Determinate the efficacy of combination velcade, melphalan, prednisone
Time frame: 1 year

3 secondary outcomes

Assess safety and tolerability
Time frame: 1 year
Assess potential superiority of this regimen versus historical controls with melphalan and prednisone alone
Time frame: 2 years
Evaluate efficacy in terms of progression-free survival and overall survival
Time frame: 5 years

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
Background: PubMed 10735013Greenlee 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.
Background2. 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
Background: PubMed 10564693Raje 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.
Background: PubMed 10761055Oken MM. Management of Myeloma: Current and Future Approaches. Cancer Control. 1998 May;5(3):218-225. doi: 10.1177/107327489800500302.
Background: PubMed 10192883Westin J. Conventional chemotherapy in multiple myeloma. Pathol Biol (Paris). 1999 Feb;47(2):169-71.
Background: PubMed 10235689Huang YW, Hamilton A, Arnuk OJ, Chaftari P, Chemaly R. Current drug therapy for multiple myeloma. Drugs. 1999 Apr;57(4):485-506. doi: 10.2165/00003495-199957040-00004.
Background: PubMed 10209667Smith ML, Newland AC. Treatment of myeloma. QJM. 1999 Jan;92(1):11-4. doi: 10.1093/qjmed/92.1.11.
Background: PubMed 9171069Bataille R, Harousseau JL. Multiple myeloma. N Engl J Med. 1997 Jun 5;336(23):1657-64. doi: 10.1056/NEJM199706053362307. No abstract available.
Background: PubMed 8289856Alexanian R, Dimopoulos M. The treatment of multiple myeloma. N Engl J Med. 1994 Feb 17;330(7):484-9. doi: 10.1056/NEJM199402173300709. No abstract available.
Background: PubMed 1531068Gregory WM, Richards MA, Malpas JS. Combination chemotherapy versus melphalan and prednisolone in the treatment of multiple myeloma: an overview of published trials. J Clin Oncol. 1992 Feb;10(2):334-42. doi: 10.1200/JCO.1992.10.2.334.
Background: PubMed 2301376Alexanian R, Barlogie B, Tucker S. VAD-based regimens as primary treatment for multiple myeloma. Am J Hematol. 1990 Feb;33(2):86-9. doi: 10.1002/ajh.2830330203.
Background: PubMed 1498331Alexanian R, Dimopoulos MA, Delasalle K, Barlogie B. Primary dexamethasone treatment of multiple myeloma. Blood. 1992 Aug 15;80(4):887-90.
Spanish association of HaematologyLink provided by the sponsor.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

San Miguel Jesús, Professor study chair

Hospital Clinico Universitario de Salamanca

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Velcade, Melphalan and Prednisone in people with Multiple Myeloma, run by PETHEMA Foundation at 19 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 12 inclusion and 11 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 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 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?

Determinate the efficacy of combination velcade, melphalan, prednisone (time frame: 1 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 NCT00388635, 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 11 Jan 2011.