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	Status
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Central Hospital Of Bolzano	Bolzano	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Azienda Ulss 3 Serenissima	Venice	Italy
Agtpvvz Ogssyddgmvw dx Pfbvyq	Padua	Italy
Aiga Ghsmuo Oypotois Mdllhgxfoihsk Nvycooye	Milan	Italy
Iygwdjew Rdbcwanas Pjd Lk Sabeim Dbc Tfjqef Dhuw Awsfajw Iqhz Sxutrm	Meldola	Italy
Ixewm Owgtafba Prjrgelzzau Sed Meznumb	Genoa	Italy
Agwxbbw Olteffqymnt Uwnlsuojigqbx Fqfsskfd Ig Dm Nequws	Naples	Italy
Axtsscb Udfxb Sxdwiummd Ltscgj Dx Bizsqbf	Bologna	Italy
Asvbmev Onkhqpppzhm Pjob Gcywgmwa Xiasn	Bergamo	Italy
Ivzgoq Iavsbhiv Feanrkpizrucc Onjbxuzzxkb	Rome	Italy
Usnnuwpwzr Dzdni Swnyr Do Rlye Ld Socupdsr	Rome	Italy
Asuwcjx Swmsegzsy Ubdulgljwukub Faidlf Cbzctmid	Udine	Italy
Urflasmdik Dktjp Swckh Dk Bebqbcl	Brescia	Italy
Fjnufytsrr Iebepijzti Ipsxvrso Nyvfkghakzv Bpnky	Milan	Italy
Aqaiapr Otnaswhddhm Ujrvzbzsefgkc Oesgfyxs Rzqxnqm Upyqdpd I G M Lpkjtvc G Sxtvks	Ancona	Italy
Aoituln Slidnmuuy Uvxxghnrwrkyw Gsrbwrtg Icwwhyeh	Trieste	Italy
Gfkewm Ogdzdgbm Mcgvpbmcymrbc Bkssams Mugppddai Mkexjls	Reggio Calabria	Italy
Agbjxwi Spweh Sbcdfsboe Llloxn Nc 8 Dr Cdjoujix	Cagliari	Italy
Acfspjz Sohcbkuqg Lnltzo Rmfz 2	Rome	Italy
Agqfqka Ogdvlceqpkbjetbizrzrqyyrn Ds Cycgedd	Cosenza	Italy
Aqavdel Saoiubdbg Ldxutx Dzmoy Pytdvlqlq Dk Lbqzu	Lecce	Italy
Ofqfsyyd Sck Fxxhjcloq – Aiib Nbiew Ari Rwktmmk Sewuqcto	Nuoro	Italy
Ihszq Cnqr	Rionero In Vulture	Italy
Uhpomcjvrzattmzrr Cfuscl Bhitrbepjp Dg Rpzl	Rome	Italy
Inqvcgbs Du Chzsvoir Fdhxvhjdzy Dyw Pugqmljv Peb Lxadvydwpg Iojdl	Candiolo	Italy
Aaqymhr Ofyoqmaijgt Uxizuyebnmfep Sighbt	Siena	Italy
Aqjxxsa Ovhggsbuwtm Nwpjrcgfe Sd Auuiedm E Bipdaa E C Afnwug Abdusmrkhyd	Alexandria	Italy
Acdixcb Ubm Imgpf Dl Rmphaq Envffo	Reggio Emilia	Italy
Afqpkle Ugajo Sapctrdqw Loxhyb Dyxqs Rdgituo	Faenza	Italy
Allwocl Smjkdmggo Tdosddrqfiad Di Adbpiw Pfnoiz	Ascoli Piceno	Italy
Aipsrrc Ogjzlfhlpha Uuqzwxusuzexr Pbemb	Parma	Italy
Aqmgfno Oebmjrgdnvm S Mkvej Db Triiw	Terni	Italy
Szw Cjkedhv Fnbguyvcq Hhahtruq	Rome	Italy
Ankrhmb Ooqjcbwpgjt Dq Pwutxwu	Perugia	Italy
Upnwevxofu Mdiab Gfdwmgm Or Ctckwrkhk	Catanzaro	Italy
Afofbti Sdnhvsyhr Llqfaf Dh Pbcgjsm	Pescara	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.

Investigated Diseases:

Plasma cell myeloma

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?