IPD in RRMM Characterized with Genomic Abnormalities of Adverse Prognostic
NCT ID: NCT03683277
Last Updated: 2025-02-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
26 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-11-03
Study Completion Date
2023-02-10
Brief Summary
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This study is a Multicenter, Open-label, Phase II study of ixazomib, plus Pomalidomide and Dexamethasone regimen (IPD) in RRMM with adverse Genomic Abnormalities.
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Detailed Description
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There is no escalation dose study, the maximum tolerated dose has already been determined in previous phase 1 escalation dose studies. The proposed dose of dexamethasone is considered standard. Patients will receive the IPd regimen until progression.
The hypothesis is that this IPd regimen based combination will eventually improve time to disease progression, with no additional toxicity, as compared to other available regimens, in this subgroup of patients with myeloma characterized with a very adverse prognosis.
Study design. This trial will study the efficacy and safety of IPd regimen in Relapsed and Refractory Multiple Myeloma with adverse Genomic Abnormalities until progression in 2 separate phases.
* Induction phase: 17 cycles - 21-days cycles Ixazomib 3 mg D1, D4, D8 and D11 Pomalidomide 4mg D1 to D14 Dexamethasone 40 mg/d D1, D8 and D15 if patient aged \<75 years Dexamethasone 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years
* Maintenance phase: until progression - 28-days cycles Ixazomib 4mg D1, D8 and D15 Pomalidomide 4mg D1 to D21
* It is not planned for the patients to receive autologous stem-cell transplantation as part of the study trial
The hypothesis is that this IPd regimen based combination will eventually improve time to disease progression, with no additional toxicity, as compared to other available regimens, in this subgroup of patients with myeloma characterized with a very adverse prognosis.
Study design. This trial will study the efficacy and safety of IPd regimen in Relapsed and Refractory Multiple Myeloma with adverse Genomic Abnormalities until progression in 2 separate phases.
* Induction phase: 17 cycles - 21-days cycles Ixazomib 3 mg D1, D4, D8 and D11 Pomalidomide 4mg D1 to D14 Dexamethasone 40 mg/d D1, D8 and D15 if patient aged \<75 years Dexamethasone 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years
* Maintenance phase: until progression - 28-days cycles Ixazomib 4mg D1, D8 and D15 Pomalidomide 4mg D1 to D21
* It is not planned for the patients to receive autologous stem-cell transplantation as part of the study trial
Conditions
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Multiple Myeloma
Relapsed and Refractory Multiple Myeloma
Genetic Condition
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
All the patients will receive the same treatment until disease progression or end of study
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Ixazomib/Pomalidomide/Dexamethasone
Single arm treatment organized in 2 separate phases
Induction phase : association of Ixazomib, Pomalidomide \& Dexamethasone (IPD) 21-days cycles - maximum of 17 cycles Ixazomib (tablets) 3 mg D1, D4, D8 and D11 Pomalidomide (tablets) 4mg D1 to D14 Dexamethasone (tablets) 40 mg/d D1, D8 and D15 if patient aged \<75 years or Dexamethasone (tablets) 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years
Maintenance phase : association of Ixazomib and Pomalidomide (IP) 28-days cycles until disease progression Ixazomib (tablets) 4mg D1, D8 and D15 Pomalidomide (tablets) 4mg D1 to D21
Group Type
EXPERIMENTAL
Ixazomib/Pomalidomide/Dexamethasone
Intervention Type
DRUG
Treatment with association of Ixazomib, Pomalidomide and Dexamethasone (IPD)
Induction phase : 21-days cycles - maximum of 17 cycles Ixazomib (tablets) 3 mg D1, D4, D8 and D11 Pomalidomide (tablets) 4mg D1 to D14 Dexamethasone (tablets) 40 mg/d D1, D8 and D15 if patient aged \<75 years Dexamethasone (tablets) 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years
Treatment with association of Ixazomib and Pomalidomide (IP) Maintenance phase : 28-days cycles until disease progression Ixazomib (tablets) 4mg D1, D8 and D15 Pomalidomide (tablets) 4mg D1 to D21
Interventions
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Ixazomib/Pomalidomide/Dexamethasone
Treatment with association of Ixazomib, Pomalidomide and Dexamethasone (IPD)
Induction phase : 21-days cycles - maximum of 17 cycles Ixazomib (tablets) 3 mg D1, D4, D8 and D11 Pomalidomide (tablets) 4mg D1 to D14 Dexamethasone (tablets) 40 mg/d D1, D8 and D15 if patient aged \<75 years Dexamethasone (tablets) 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years
Treatment with association of Ixazomib and Pomalidomide (IP) Maintenance phase : 28-days cycles until disease progression Ixazomib (tablets) 4mg D1, D8 and D15 Pomalidomide (tablets) 4mg D1 to D21
Intervention Type
DRUG
Other Intervention Names
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Multicentric, phase 2, RRMM, refractory, relapse, myeloma
Eligibility Criteria
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Inclusion Criteria
1. Male or female patients 18 years or older.
2. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
3. Life expectancy \> 3 months.
4. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
5. Presence - at diagnosis or at relapse - of one of the following adverse genomic abnormalities determined using Interphase fluorescence in situ hybridization and Single nucleotide polymorphism (FISH/SNP) techniques at a significant rate validated centrally by Pr AVET - LOISEAU:
* deletion 17p
* and/ or translocation (4; 14)
6. Must have an RRMM and have received a Lenalidomide line of treatment
7. Must have a Progressive Multiple Myeloma (MM) according to IMWG consensus recommendations for multiple myeloma treatment response criteria (DURIE 2007, RAJKUMAR 2011) :
* Increase of 25% from lowest response value in any one of the following:
* Serum M-component (absolute increase must be ≥ 0.5 g/dL),
* Urine M-component (absolute increase must be ≥ 200 mg/24 hours),
* Only in subjects without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC (Free Light-Chain) levels (absolute increase must be \>10 mg/dL)
* Bone marrow plasma cell percentage: the absolute percentage must be \>10%
* Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
* Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC (Plasma Cell) proliferative disorder
8. Must have a measurable disease as defined by the following:
* IgG (immunoglobulin G) and IgA (immunoglobulin A) (serum M-component \> 5g/l)
* IgD (immunoglobulin D) (serum M-component \> 0.5g/l)
* Light chain (Bence Jones \> 200mg/24h)
* For MM without measurable serum or urine M protein, involved FLC ≥100 mg/l and FLC abnormal ratio.
9. Patients must meet the following clinical laboratory criteria:
* Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
* Total bilirubin ≤1.5 x the upper limit of the normal range (ULN).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
* Calculated creatinine clearance ≥ 30 mL/min MDRD (Modification of Diet in Renal Disease) formula should be used for calculating creatinine clearance values: http://mdrd.com/
10. Able to undergo antithrombotic prophylactic treatment. HBPM (low weight heparin) is preferred. In case of anti-Vitamin K Agent, INR (international normalized ratio) must be used
11. Female patients who:
* Have been postmenopausal for at least 2 years before the screening visit, OR
* Are surgically sterile, OR
* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
12. Patients agree:
* not to share study medication with any other person and to return all unused study drugs to the investigator.
* to abstain from donating blood while taking the study drug therapy and for one week following discontinuation of the study drug therapy.
13. Must be able to adhere to the study visit schedule and other protocol requirements including the pregnancy prevention program as detailed in section 13.4 of protocol
14. Affiliated with an appropriate social security system.
2. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
3. Life expectancy \> 3 months.
4. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
5. Presence - at diagnosis or at relapse - of one of the following adverse genomic abnormalities determined using Interphase fluorescence in situ hybridization and Single nucleotide polymorphism (FISH/SNP) techniques at a significant rate validated centrally by Pr AVET - LOISEAU:
* deletion 17p
* and/ or translocation (4; 14)
6. Must have an RRMM and have received a Lenalidomide line of treatment
7. Must have a Progressive Multiple Myeloma (MM) according to IMWG consensus recommendations for multiple myeloma treatment response criteria (DURIE 2007, RAJKUMAR 2011) :
* Increase of 25% from lowest response value in any one of the following:
* Serum M-component (absolute increase must be ≥ 0.5 g/dL),
* Urine M-component (absolute increase must be ≥ 200 mg/24 hours),
* Only in subjects without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC (Free Light-Chain) levels (absolute increase must be \>10 mg/dL)
* Bone marrow plasma cell percentage: the absolute percentage must be \>10%
* Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
* Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC (Plasma Cell) proliferative disorder
8. Must have a measurable disease as defined by the following:
* IgG (immunoglobulin G) and IgA (immunoglobulin A) (serum M-component \> 5g/l)
* IgD (immunoglobulin D) (serum M-component \> 0.5g/l)
* Light chain (Bence Jones \> 200mg/24h)
* For MM without measurable serum or urine M protein, involved FLC ≥100 mg/l and FLC abnormal ratio.
9. Patients must meet the following clinical laboratory criteria:
* Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
* Total bilirubin ≤1.5 x the upper limit of the normal range (ULN).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
* Calculated creatinine clearance ≥ 30 mL/min MDRD (Modification of Diet in Renal Disease) formula should be used for calculating creatinine clearance values: http://mdrd.com/
10. Able to undergo antithrombotic prophylactic treatment. HBPM (low weight heparin) is preferred. In case of anti-Vitamin K Agent, INR (international normalized ratio) must be used
11. Female patients who:
* Have been postmenopausal for at least 2 years before the screening visit, OR
* Are surgically sterile, OR
* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
12. Patients agree:
* not to share study medication with any other person and to return all unused study drugs to the investigator.
* to abstain from donating blood while taking the study drug therapy and for one week following discontinuation of the study drug therapy.
13. Must be able to adhere to the study visit schedule and other protocol requirements including the pregnancy prevention program as detailed in section 13.4 of protocol
14. Affiliated with an appropriate social security system.
Exclusion Criteria
1. Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation.
2. Patients not having receive Lenalidomide
3. Pregnant or breast feeding females
4. Known positive for HIV or active hepatitis type B or C.
5. Patients with non-secretory MM
6. Patient with terminal renal failure that require dialysis and clearance creatinine \< 30ml/min
7. Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for ≥ 5 years.
8. Prior local irradiation within two weeks before first dose\*
\*However, an exception (that is patients allowed to remain in the treatment phase of the study) is made for radiation therapy to a pathological fracture site to enhance bone healing or to treat post-fracture pain that is refractory to narcotic analgesics because pathologic bone fractures do not by themselves fulfill a criterion for disease progression.)
9. Evidence of central nervous system (CNS) involvement
10. Unable to take corticotherapy at study entry, Ixazomib or pomalidomide
11. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment
12. Ongoing Cardiac dysfunction: specify e.g. uncontrolled hypertension, MI (Myocardial Infarction) within 6 months, unstable Angina pectoris, Cardiac arrhythmia Grade 2 or higher
13. Patients planned to receive a transplantation while on IPd protocol
14. Patients who have had Ixazomib and Pomalidomide therapy as a previous line
15. Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
16. Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy.
17. Inability or unwillingness to comply with birth control requirements
18. Unable to take antithrombotic medicines at study entry
19. Major surgery within 14 days before enrollment.
20. Systemic treatment, within 14 days before the first dose of ixazomib and Pomalidomide, with strong CYP3A (Cytochrome P450 3A) inducers (rifampicin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort.
21. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
22. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
23. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib and Pomalidomide including difficulty swallowing.
24. Patient has ≥ Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
25. Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.
26. Subjects under juridical protection guardianship or tutelage measure
2. Patients not having receive Lenalidomide
3. Pregnant or breast feeding females
4. Known positive for HIV or active hepatitis type B or C.
5. Patients with non-secretory MM
6. Patient with terminal renal failure that require dialysis and clearance creatinine \< 30ml/min
7. Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for ≥ 5 years.
8. Prior local irradiation within two weeks before first dose\*
\*However, an exception (that is patients allowed to remain in the treatment phase of the study) is made for radiation therapy to a pathological fracture site to enhance bone healing or to treat post-fracture pain that is refractory to narcotic analgesics because pathologic bone fractures do not by themselves fulfill a criterion for disease progression.)
9. Evidence of central nervous system (CNS) involvement
10. Unable to take corticotherapy at study entry, Ixazomib or pomalidomide
11. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment
12. Ongoing Cardiac dysfunction: specify e.g. uncontrolled hypertension, MI (Myocardial Infarction) within 6 months, unstable Angina pectoris, Cardiac arrhythmia Grade 2 or higher
13. Patients planned to receive a transplantation while on IPd protocol
14. Patients who have had Ixazomib and Pomalidomide therapy as a previous line
15. Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
16. Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy.
17. Inability or unwillingness to comply with birth control requirements
18. Unable to take antithrombotic medicines at study entry
19. Major surgery within 14 days before enrollment.
20. Systemic treatment, within 14 days before the first dose of ixazomib and Pomalidomide, with strong CYP3A (Cytochrome P450 3A) inducers (rifampicin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort.
21. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
22. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
23. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib and Pomalidomide including difficulty swallowing.
24. Patient has ≥ Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
25. Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.
26. Subjects under juridical protection guardianship or tutelage measure
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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AXONAL
UNKNOWN
Sponsor Role
collaborator
Nantes University Hospital
OTHER
Sponsor Role
collaborator
University Hospital, Grenoble
OTHER
Sponsor Role
collaborator
Euraxi Pharma
INDUSTRY
Sponsor Role
collaborator
QPS Holdings LLC
INDUSTRY
Sponsor Role
collaborator
Bristol-Myers Squibb
INDUSTRY
Sponsor Role
collaborator
Takeda
INDUSTRY
Sponsor Role
collaborator
Intergroupe Francophone du Myelome
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Xavier LELEU, Pr
Role: PRINCIPAL_INVESTIGATOR
Poitiers University Hospital
Locations
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CHU Angers
Angers, , France
Site Status
CH Avignon - Centre Hospitalier H.Duffaut
Avignon, , France
Site Status
Centre hospitalier de la côte basque
Bayonne, , France
Site Status
Hôpital Avicenne
Bobigny, , France
Site Status
CHU de Caen
Caen, , France
Site Status
Hôpital Privé Sévigné
Cesson-Sévigné, , France
Site Status
CHU Henri Mondor
Créteil, , France
Site Status
CHU de Dijon
Dijon, , France
Site Status
Centre hospitalier de Dunkerque
Dunkirk, , France
Site Status
CHU de Grenoble
Grenoble, , France
Site Status
Centre hospitalier départemental de Vendée
La Roche-sur-Yon, , France
Site Status
CHRU Hôpital Claude Huriez
Lille, , France
Site Status
CHU de Limoges
Limoges, , France
Site Status
CHU Saint Eloi
Montpellier, , France
Site Status
CHRU Hôtel Dieu
Nantes, , France
Site Status
Hôpital de l'Archet 1
Nice, , France
Site Status
Hôpital Saint Louis
Paris, , France
Site Status
CHU Bordeaux - Hôpital Haut Leveque
Pessac, , France
Site Status
Centre Hospitalier de Périgueux
Périgueux, , France
Site Status
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Site Status
CHU de Poitiers
Poitiers, , France
Site Status
CHU de Reims Hôpital Robert Debré
Reims, , France
Site Status
CHU Pontchaillou
Rennes, , France
Site Status
Centre Henri Becquerel
Rouen, , France
Site Status
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, , France
Site Status
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse, , France
Site Status
CHRU Bretonneau
Tours, , France
Site Status
Hôpitaux de Brabois - CHRU de Nancy
Vandœuvre-lès-Nancy, , France
Site Status
Countries
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France
References
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Moreau P, Attal M, Garban F, Hulin C, Facon T, Marit G, Michallet M, Doyen C, Leyvraz S, Mohty M, Wetterwald M, Mathiot C, Caillot D, Berthou C, Benboubker L, Garderet L, Chaleteix C, Traulle C, Fuzibet JG, Jaubert J, Lamy T, Casassus P, Dib M, Kolb B, Dorvaux V, Grosbois B, Yakoub-Agha I, Harousseau JL, Avet-Loiseau H; SAKK; IFM Group. Heterogeneity of t(4;14) in multiple myeloma. Long-term follow-up of 100 cases treated with tandem transplantation in IFM99 trials. Leukemia. 2007 Sep;21(9):2020-4. doi: 10.1038/sj.leu.2404832. Epub 2007 Jul 12.
Reference Type
BACKGROUND
Bobin A, Manier S, De Keizer J, Srimani JK, Hulin C, Karlin L, Caillot D, Lafon I, Mariette C, Araujo C, Arnulf B, Bareau B, Belhadj K, Benboubker L, Braun T, Calmettes C, Decaux O, Dib M, Demarquette H, Jacquet C, Sonntag C, Godet S, Jaccard A, Lenain P, Macro M, Richez-Olivier V, Tiab M, Vincent L, Zerazhi H, Petillon MO, Rollet S, Gardeney H, Durand G, Levy A, Touzeau C, Perrot A, Moreau P, Facon T, Corre J, Ragot S, Avet-Loiseau H, Leleu X. Ixazomib, pomalidomide and dexamethasone in relapsed or refractory multiple myeloma characterized with highrisk cytogenetics: the IFM 2014-01 study. Haematologica. 2025 Mar 1;110(3):758-763. doi: 10.3324/haematol.2024.285916. No abstract available.
Reference Type
BACKGROUND
Assouline, S., et al. Once-weekly MLN9708, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma: results of a phase 1 dose-escalation study in 17th EHA Annual Congress. 2012. Amsterdam, the Netherlands
Reference Type
BACKGROUND
Avet-Loiseau H, Attal M, Moreau P, Charbonnel C, Garban F, Hulin C, Leyvraz S, Michallet M, Yakoub-Agha I, Garderet L, Marit G, Michaux L, Voillat L, Renaud M, Grosbois B, Guillerm G, Benboubker L, Monconduit M, Thieblemont C, Casassus P, Caillot D, Stoppa AM, Sotto JJ, Wetterwald M, Dumontet C, Fuzibet JG, Azais I, Dorvaux V, Zandecki M, Bataille R, Minvielle S, Harousseau JL, Facon T, Mathiot C. Genetic abnormalities and survival in multiple myeloma: the experience of the Intergroupe Francophone du Myelome. Blood. 2007 Apr 15;109(8):3489-95. doi: 10.1182/blood-2006-08-040410. Epub 2007 Jan 5.
Reference Type
BACKGROUND
Avet-Loiseau H, Attal M, Campion L, Caillot D, Hulin C, Marit G, Stoppa AM, Voillat L, Wetterwald M, Pegourie B, Voog E, Tiab M, Banos A, Jaubert J, Bouscary D, Macro M, Kolb B, Traulle C, Mathiot C, Magrangeas F, Minvielle S, Facon T, Moreau P. Long-term analysis of the IFM 99 trials for myeloma: cytogenetic abnormalities [t(4;14), del(17p), 1q gains] play a major role in defining long-term survival. J Clin Oncol. 2012 Jun 1;30(16):1949-52. doi: 10.1200/JCO.2011.36.5726. Epub 2012 Apr 30.
Reference Type
BACKGROUND
Avet-Loiseau H, Leleu X, Roussel M, Moreau P, Guerin-Charbonnel C, Caillot D, Marit G, Benboubker L, Voillat L, Mathiot C, Kolb B, Macro M, Campion L, Wetterwald M, Stoppa AM, Hulin C, Facon T, Attal M, Minvielle S, Harousseau JL. Bortezomib plus dexamethasone induction improves outcome of patients with t(4;14) myeloma but not outcome of patients with del(17p). J Clin Oncol. 2010 Oct 20;28(30):4630-4. doi: 10.1200/JCO.2010.28.3945. Epub 2010 Jul 19.
Reference Type
BACKGROUND
Bergsagel PL, Mateos MV, Gutierrez NC, Rajkumar SV, San Miguel JF. Improving overall survival and overcoming adverse prognosis in the treatment of cytogenetically high-risk multiple myeloma. Blood. 2013 Feb 7;121(6):884-92. doi: 10.1182/blood-2012-05-432203. Epub 2012 Nov 19.
Reference Type
BACKGROUND
Chauhan D, Tian Z, Zhou B, Kuhn D, Orlowski R, Raje N, Richardson P, Anderson KC. In vitro and in vivo selective antitumor activity of a novel orally bioavailable proteasome inhibitor MLN9708 against multiple myeloma cells. Clin Cancer Res. 2011 Aug 15;17(16):5311-21. doi: 10.1158/1078-0432.CCR-11-0476. Epub 2011 Jun 30.
Reference Type
BACKGROUND
Chow, L.Q., et al. MLN9708, an investigational proteasome inhibitor, in patients with solid tumors; Updated phase 1 results in Head and Neck Symposium. 2012. Phoenix, AZ
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Jagannath S, Richardson PG, Sonneveld P, Schuster MW, Irwin D, Stadtmauer EA, Facon T, Harousseau JL, Cowan JM, Anderson KC. Bortezomib appears to overcome the poor prognosis conferred by chromosome 13 deletion in phase 2 and 3 trials. Leukemia. 2007 Jan;21(1):151-7. doi: 10.1038/sj.leu.2404442. Epub 2006 Nov 9.
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Merlini, G., et al. MLN9708, a Novel, Investigational Oral Proteasome Inhibitor, in Patients with Relapsed or Refractory Light-Chain Amyloidosis (AL): Results of a Phase 1 Study in 54th ASH Annual Meeting and Exposition. 2012. Atlanta, Georgia
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Rajkumar SV, Harousseau JL, Durie B, Anderson KC, Dimopoulos M, Kyle R, Blade J, Richardson P, Orlowski R, Siegel D, Jagannath S, Facon T, Avet-Loiseau H, Lonial S, Palumbo A, Zonder J, Ludwig H, Vesole D, Sezer O, Munshi NC, San Miguel J; International Myeloma Workshop Consensus Panel 1. Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Blood. 2011 May 5;117(18):4691-5. doi: 10.1182/blood-2010-10-299487. Epub 2011 Feb 3.
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Sonneveld P, Schmidt-Wolf IG, van der Holt B, El Jarari L, Bertsch U, Salwender H, Zweegman S, Vellenga E, Broyl A, Blau IW, Weisel KC, Wittebol S, Bos GM, Stevens-Kroef M, Scheid C, Pfreundschuh M, Hose D, Jauch A, van der Velde H, Raymakers R, Schaafsma MR, Kersten MJ, van Marwijk-Kooy M, Duehrsen U, Lindemann W, Wijermans PW, Lokhorst HM, Goldschmidt HM. Bortezomib induction and maintenance treatment in patients with newly diagnosed multiple myeloma: results of the randomized phase III HOVON-65/ GMMG-HD4 trial. J Clin Oncol. 2012 Aug 20;30(24):2946-55. doi: 10.1200/JCO.2011.39.6820. Epub 2012 Jul 16.
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Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.
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BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IFM 2014-01
Identifier Type: -
Identifier Source: org_study_id
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