SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients
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|ClinicalTrials.gov Identifier: NCT01749969|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2012
Last Update Posted : May 13, 2019
- To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and dexamethasone (LD) in patients with relapsed or refractory multiple myeloma.
- Expansion Phase Only: To further evaluate preliminary evidence of antitumor activity (objective response rate [ORR]) of SAR650984 (isatuximab) in combination with LD using International Myeloma Working Group (IMWG) criteria.
- To evaluate the safety, including immunogenicity, of SAR650984 (isatuximab) in combination with LD in relapsed or refractory multiple myeloma. The severity, frequency and incidence of all toxicities will be assessed.
- To evaluate the pharmacokinetics (PK) of SAR650984 (isatuximab) when administered in combination with LD and the PK of lenalidomide in combination with SAR650984 and dexamethasone.
- To assess the relationship between clinical (adverse event [AE] and/or tumor response) effects and pharmacologic parameters (PK/pharmacodynamics), and/or biologic (correlative laboratory) results.
- For the dose expansion phase, estimate the activity (ORR) using IMWG defined response criteria of SAR650984 (isatuximab) plus LD.
- To describe progression-free survival (PFS) in patients treated with this combination.
|Condition or disease||Intervention/treatment||Phase|
|Plasma Cell Myeloma||Drug: isatuximab SAR650984 Drug: lenalidomide Drug: dexamethasone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study of SAR650984 (Anti-CD38 mAb) in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||February 6, 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: SAR650984 (isatuximab)
SAR650984 (isatuximab) (escalating dose) plus lenalidomide 25 mg on Days 1 to 21 plus dexamethasone 40 mg on Days 1, 8, 15, 22 in 28-day cycles for all cohorts up to disease progression.
For Q2W cohorts: SAR650984 (isatuximab) on Days 1 and 15 of every cycle. For QW/Q2W cohorts: SAR650984 (isatuximab) on Days 1, 8, 15, and 22 of first cycle and Days 1 and 15 of every subsequent cycle.
Drug: isatuximab SAR650984
Pharmaceutical form:solution Route of administration: intravenous
Pharmaceutical form:capsules Route of administration: oral
Other Name: Revlimid
Pharmaceutical form:solution or tablet Route of administration: intravenous or oral
- Number of patients with adverse events when treated with SAR650984 (isatuximab) in combination with LD [ Time Frame: Up to 30 days for patients experiencing progressive disease and continuously while patients are on treatment ]
- Preliminary assessment of overall response rate [ Time Frame: 9 months from the last investigational medicinal product (IMP)/non-IMP (NIMP) administration ]
- Preliminary assessment of progression-free survival (PFS) [ Time Frame: Up to disease progression ]
- Assessment of PK parameters - maximum concentration (Cmax) [ Time Frame: Up to disease progression plus 60 days ]
- Assessment of PK parameters - time to reach Cmax (Tmax) [ Time Frame: Up to disease progression plus 60 days ]
- Assessment of PK parameters - concentration observed at end of infusion (Ceoi) [ Time Frame: Up to disease progression plus 60 days ]
- Assessment of PK parameters - area under the plasma concentration versus time curve over the dosing interval (AUCtau) [ Time Frame: Up to disease progression plus 60 days ]
- Assessment of PK parameters - plasma concentration observed just before treatment administration during repeated dosing (Ctrough) [ Time Frame: Up to disease progression plus 60 days ]
- Number of CD38 receptors occupied by SAR650984 (isatuximab) [ Time Frame: Up to disease progression plus 60 days ]
- CD38 receptor density [ Time Frame: Up to disease progression plus 60 days ]
- Immunogenicity: Number of anti-SAR650984 (isatuximab) antibodies in response to SAR650984 (isatuximab) [ Time Frame: Up to disease progression plus 60 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749969
|United States, California|
|Investigational Site Number 840004|
|San Francisco, California, United States, 94117|
|United States, Florida|
|Investigational Site Number 840001|
|Tampa, Florida, United States, 33612|
|United States, Missouri|
|Investigational Site Number 840002|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Investigational Site Number 840005|
|New York, New York, United States, 10021|
|United States, Ohio|
|Investigational Site Number 840003|
|Columbus, Ohio, United States, 43210|
|Study Director:||Clinical Sciences & Operations||Sanofi|