Study on Carfilzomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Transplant

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What is this study about?

This clinical trial is focused on studying treatments for Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study involves patients who have been newly diagnosed with this condition and are eligible for a procedure called an autologous transplant, where a patient’s own stem cells are used to replace damaged or diseased bone marrow.

The trial will test different combinations of medications to see how well they work in treating Multiple Myeloma. The medications being studied include Carfilzomib, Lenalidomide, Cyclophosphamide, and Dexamethasone. Carfilzomib is given as an infusion, which means it is administered directly into the bloodstream through a vein, while Lenalidomide, Cyclophosphamide, and Dexamethasone are taken orally in capsule form. The study will compare the effectiveness of these medications when used in different combinations and treatment plans, including before and after the transplant, or as a continuous treatment without a transplant.

The purpose of the study is to determine how effective these medication combinations are in achieving a significant reduction in cancer cells, known as a very good partial response, after four cycles of treatment. The study will also look at how long patients remain free from disease progression during the maintenance phase, where treatment is continued to help keep the cancer from returning. Participants will be monitored throughout the study to assess the outcomes of the different treatment approaches.

1 induction treatment

The induction phase involves the administration of medications to prepare for potential transplant. Two different combinations of drugs are used: carfilzomib, lenalidomide, and dexamethasone or carfilzomib, cyclophosphamide, and dexamethasone.

The treatment is administered over 4 cycles. Carfilzomib is given intravenously, while lenalidomide and cyclophosphamide are taken orally in capsule form.

2 transplant and consolidation

For patients eligible for a transplant, an autologous stem cell transplant may be performed. This involves using the patient’s own stem cells to help restore bone marrow function.

Following the transplant, a consolidation phase occurs, which involves further treatment with the same drug combinations used in the induction phase to strengthen the response to treatment.

3 continuous treatment

For patients not undergoing a transplant, continuous treatment with carfilzomib, lenalidomide, and dexamethasone is administered over 12 cycles.

This phase aims to maintain the response achieved during the induction phase.

4 maintenance treatment

After the consolidation or continuous treatment phase, maintenance therapy begins. This involves the use of lenalidomide alone or in combination with carfilzomib.

The goal of maintenance therapy is to prolong the period of remission and prevent disease progression.

Who Can Join the Study?

Must be 18 years or older.
Must have been newly diagnosed with Multiple Myeloma (MM), a type of blood cancer.
Must be eligible for autologous stem cell transplant (ASCT), a procedure where a patient’s own stem cells are used.
Must have a measurable disease according to specific medical guidelines.
Must provide voluntary written informed consent, meaning you agree to participate after understanding the study.
Must agree to use acceptable methods of contraception to prevent pregnancy during the study.
Must have a Karnofsky performance status of 60% or higher, which is a way to measure your ability to perform daily activities.
Must have certain clinical laboratory values within normal ranges, such as:
- Platelet count of at least 75 x 10⁹/L (or 50 x 10⁹/L if more than 50% of bone marrow is affected by myeloma).
- Absolute neutrophil count (ANC) of at least 1 x 10⁹/L without using growth factors.
- Corrected serum calcium of 14 mg/dL or less.
- Alanine transaminase (ALT) and Aspartate transaminase (AST) levels no more than 3 times the upper limit of normal (ULN).
- Total bilirubin no more than 2 times the ULN.
- Creatinine clearance of at least 30 mL/minute, which measures kidney function.
- Left ventricular ejection fraction (LVEF) of at least 40%, which measures heart function.
Must have a life expectancy of at least 3 months.

Who Cannot Join the Study?

Patients who have not been newly diagnosed with Multiple Myeloma (MM). Multiple Myeloma is a type of cancer that affects certain cells in the bone marrow.
Patients who are not eligible for an autologous transplant. An autologous transplant is a procedure where a patient’s own stem cells are used to replace damaged or diseased bone marrow.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Azienda Sanitaria Locale Roma 2	Rome	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
San Camillo Forlanini Hospital	Rome	Italy
Azienda Ospedaliera Di Perugia	Perugia	Italy
Azienda Ulss 3 Serenissima	Venice	Italy
Azienda Sanitaria Locale Di Pescara	Pescara	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Azienda Socio Sanitaria Locale N. 8 Di Cagliari	Cagliari	Italy
Azienda Ospedaliera di Padova	Padua	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Central Hospital Of Bolzano	Bolzano	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Sanitaria Territoriale Di Ascoli Piceno	Ascoli Piceno	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
IRCCS CROB	Rionero In Vulture	Italy
Aljbcrj Oasrbimigpo Ufwmgkukkvdap Pmudl	Parma	Italy
Iqwnkr Iyjqtonq Fznrdkomiisbm Ovemvlubtdr	Rome	Italy
Ahsdmqi Ojoppccxmmkrpqugywddodctm Dl Camfwqk	Cosenza	Italy
Orwjakbr Sst Fpjrlyose – Acbp Nqcjl Acz Rbslrvt Saarzysn	Nuoro	Italy
Apgabyq Sjwozurtw Llxetr Dbvon Puulxqzlf Dq Lcymz	Lecce	Italy
Ipvudecy Rjjvfdsly Pwd Le Srxydz Dvu Texfrc Dyub Aihzfxd Iifl Sawmnm	Meldola	Italy
Afbfxxc Olhhcuuhhea Umqmgpfkyjbfn Skgcyg	Siena	Italy
Artkxwx Oxzgqbjmbrh Nnjxwrhtb Sd Avkaqxa E Biromi E C Axjupf Amgkgeltapo	Alexandria	Italy
Aqfmsjb Ugo Ishhv Dk Rrpjfq Eqbuxs	Reggio Emilia	Italy
Arapvpg Ultms Smiuumsav Lynwhu Dm Bauqvkw	Bologna	Italy
Afensaj Omgaqnfsysb Pmrq Gkmuylpd Xgblj	Bergamo	Italy
Ulybzfqech Dppri Sqriu Dg Rysb Lo Ssdxoeyi	Rome	Italy
Urovhnajdv Mdduw Gqkzcuv Og Csgxtjpdx	Catanzaro	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	19.09.2015

Trial locations

Investigated drugs:

Carfilzomib is a medication used in the treatment of multiple myeloma, a type of blood cancer. It works by blocking the action of proteasomes, which are structures inside cells that break down proteins. By inhibiting these proteasomes, carfilzomib causes cancer cells to die.

Cyclophosphamide is a chemotherapy drug that is used to treat various types of cancer, including multiple myeloma. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

Dexamethasone is a type of steroid medication that is often used in combination with other drugs to treat multiple myeloma. It helps reduce inflammation and can also help kill cancer cells.

Lenalidomide is a medication that modifies the immune system and has anti-cancer effects. It is used to treat multiple myeloma by helping the immune system attack cancer cells and by directly inhibiting their growth.

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to symptoms such as bone pain, anemia, and kidney problems. As the disease progresses, it can cause bones to become weak and more prone to fractures. Patients may also experience frequent infections due to a weakened immune system. Over time, the accumulation of abnormal proteins produced by the cancerous cells can lead to organ damage. The disease typically progresses in stages, with symptoms worsening as the number of cancerous cells increases.

Trial ID:

2024-516630-35-01

Protocol code:

2024-516630-35-00

NCT ID:

NCT02203643

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Carfilzomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Transplant

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?