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Multiple MyelomaPhase 2RMPTNCT00961467

RMPT for Relapsed/Refractory Multiple Myeloma

A Phase 2 study testing Revlimid, Melphalan, Prednisone, Thalidomide in people with Multiple Myeloma, run by Fondazione EMN Italy Onlus at 1 site in Italy.

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

After the discovery of melphalan and prednisone (MP), many clinical trials evaluated the efficacy of combination chemotherapy, such as VMCP, VBAP, MOCCA in multiple myeloma (MM) patients, without significant clinical benefit. 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?
Revlimid, Melphalan, Prednisone, Thalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteItaly
Study dates
Feb 2007to Apr 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is of a legally consenting age as defined by local regulations.
  • 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
  • Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method)(Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of Lenalidomide therapy.
  • Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of Lenalidomide therapy.
  • Patient was previously diagnosed with symptomatic multiple myeloma based on standard criteria (12), and has measurable disease, defined as follows:
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  • Secretory myeloma: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours;
  • Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan).
  • Patient is relapsed or refractory after one or two lines of treatment
  • Patient has a Karnofsky performance status ≥ 60%.
  • Patient has a life-expectancy > 3 months.
  • Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1):
  • Platelet count ³ 100 x 109/L without transfusion support within 7 days before the test
  • Absolute neutrophil count ³ 1.0 x 109/L without the use of growth factors
  • Total bilirubin £ 1.5 x the ULN
  • AST (SGOT) and ALT (SGPT) £ 2.5 x ULN
  • Corrected serum calcium < 14 mg/dl (3.5 mmol/L)
  • Calculated or measured creatinine clearance: ≥ 20 mL/minute

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or beast feeding females.
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Use of any other concomitant standard/experimental anti-myeloma drug or therapy
  • Prior induction therapy with R-MP or M-PT association
  • Any of the following laboratory abnormalities:
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  • Platelet count < 100 ´ 109/L.
  • Absolute neutrophil count <1.0 ´ 109/L.
  • Aspartate transaminase (AST): >2.5 x the upper limit of normal (ULN).
  • Alanine transaminase (AST): > 2.5 x the ULN.
  • Total bilirubin: > 1.5 x the ULN.
  • Corrected serum calcium >14 mg/dL (3.5 mmol/L).
  • Calculated or measured creatinine clearance <20 mL/minute
  • Known positive for HIV or active infectious hepatitis, type B or C.
  • Patient has ³Grade 2 peripheral neuropathy within 14 days before enrollment.
  • Known hypersensitivity to thalidomide.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedaliera S Giovanni Battista

    Torino, Italy/Torino, 10126

Other trials in Italy

About this study

Official title: Lenalidomide, Melphalan, Prednisone, and Thalidomide (RMPT) for Relapsed/Refractory Multiple Myeloma

After the discovery of melphalan and prednisone (MP), many clinical trials evaluated the efficacy of combination chemotherapy, such as VMCP, VBAP, MOCCA in multiple myeloma (MM) patients, without significant clinical benefit. After 40 years, the combination of MP with thalidomide (MPT) or lenalidomide (MPR) or bortezomib (MPV) have finally and consistently shown additive or synergistic effects.In advanced MM, the combination of melphalan, prednisone and thalidomide induced 12% very good partial response (VGPR) rate, while the combination of melphalan and bortezomib showed 15% near complete remission (nCR) rate. In relapsed patients, the combination of bortezomib with MPT (VMPT) induced 43% VGPR rate. Preliminary results indicate that VMPT may induce a CR rate of around 50% in newly diagnosed patients (unpublished results).In preclinical studies thalidomide showed more anti-angiogenesis activity, while lenalidomide showed more immunomodulatory effects, thus suggesting a combined clinical approach for these two drugs. The toxicity profile of lenalidomide is completely different from that of thalidomide and no cumulative toxicities are expected, again suggesting a combination approach. This study will evaluate the safety and efficacy of combining Lenalidomide, Melphalan, Prednisone and Thalidomide (R-MPT) as salvage treatment for relapsed/refractory myeloma patients. This association might further increase the response rate achieved by the standard oral MPT or MPR regimens.

Being tested
Revlimid, Melphalan, Prednisone, Thalidomide
Keywords
Relapsed/ refractory Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Revlimid, Melphalan, Prednisone, ThalidomideDrug

    Thalidomide was administered at 50 mg/day.

  • Revlimid, Melphalan, Prednisone, ThalidomideDrug

    Thalidomide was administered at 100 mg/day.

Study groups in NCT00961467
Study groupRoleWhat they receive
RMPT (Arm A -thalidomide 50 mg/day)ExperimentalNot described
Receives: Drug: Revlimid, Melphalan, Prednisone, Thalidomide
RMPT (Arm B - thalidomide 100 mg/day)ExperimentalNot described
Receives: Drug: Revlimid, Melphalan, Prednisone, Thalidomide

What is being measured

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

  1. Myeloma response rate in terms of partial remission (PR) and very good partial remission (VGPR)

    Measured: 4 years

Secondary outcomes (1)

  1. progression free survival and overall survival

    Measured: 4 years

Timeline

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

  1. First posted19 Aug 2009 (estimated)
  2. Study startFeb 2007
  3. Primary completionMar 2008
  4. Study completionApr 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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00961467
Sponsor's protocol ID
RV MM PI 210
Acronym
RMPT
Status last verified
May 2016
First submitted
14 Aug 2009
Last updated
10 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Revlimid, Melphalan, Prednisone, Thalidomide in people with Multiple Myeloma, run by Fondazione EMN Italy Onlus at 1 site in Italy.

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 18 inclusion and 16 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 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

Myeloma response rate in terms of partial remission (PR) and very good partial remission (VGPR) (time frame: 4 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 NCT00961467.

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 10 May 2016.

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