Trial Outcomes & Findings for Sorafenib, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT00687674)

Last Updated: 2019-08-20

Results Overview

Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Description of Grades: Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

up to 3 years

Results posted on

2019-08-20

Participant Flow

Thirteen (13) participants were recruited at Mayo Clinic between August 2008 and March 2010.

This was a phase I/II trial. A total of 13 participants were accrued, all to the phase I portion. This trial was terminated due to study design and toxicity during the phase I; therefore, the phase II portion will never open. No results from the phase II portion are available.

Participant milestones

Participant milestones
Measure	Sorafenib + Lenalidomide + Dexamethasone
Overall Study STARTED	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sorafenib, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib + Lenalidomide + Dexamethasone n=13 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Prior Lenalidomide Yes	2 participants n=5 Participants
Prior Lenalidomide No	11 participants n=5 Participants
Prior Transplant Yes	12 participants n=5 Participants
Prior Transplant No	1 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 years

Population: One participant refused further treatment prior to being assessed for adverse events.

Outcome measures

Outcome measures
Measure	Sorafenib + Lenalidomide + Dexamethasone n=12 Participants
Number of Participants With a Grade 3 and 4 Adverse Event (Phase I)	11 participants

PRIMARY outcome

Timeframe: Duration on Treatment (up to 3 years)

Population: No participants proceeded to Phase II for evaluation.

Response that was confirmed on 2 consecutive evaluations during treatment * CR: Complete disappearance of M-protein from serum \& urine on immunofixation, \<5% plasma cells in bone marrow (BM) * sCR: CR plus normal FLC ratio \& absence of clonal cells in BM * VGPR: \>=90% reduction in serum M-component; Urine M-Component \<100 mg per 24 hours; \<=5% plasma cells in BM * PR: \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From registration to death (up to 3 years)

Population: No participants proceeded to Phase II for evaluation.

Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 2 years from registration. The median OS with 95%CI was estimated using the Kaplan Meier method

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From registration to progression (up to 3 years)

Population: No participants proceeded to Phase II for evaluation.

Time to disease progression (TTP) was defined as the time from registration to progression. The median TTP with 95%CI was estimated using the Kaplan Meier method. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in: * Serum M-component (absolute increase \>= 0.5g/dl) * Urine M-component (absolute increase \>= 200mg/24hour * Difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl * Bone marrow plasma cell percentage (absolute increase of \>=10%)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre and Post treatment (up to 3 years)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre and Post treatment (up to 3 years)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post treatment

Outcome measures

Outcome data not reported

Adverse Events

Sorafenib + Lenalidomide + Dexamethasone

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sorafenib + Lenalidomide + Dexamethasone n=13 participants at risk
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 1
Investigations Leukopenia	7.7% 1/13 • Number of events 1
Skin and subcutaneous tissue disorders Rash	7.7% 1/13 • Number of events 1

Other adverse events

Other adverse events
Measure	Sorafenib + Lenalidomide + Dexamethasone n=13 participants at risk
Blood and lymphatic system disorders Anemia	84.6% 11/13 • Number of events 53
Gastrointestinal disorders Diarrhea	30.8% 4/13 • Number of events 9
Gastrointestinal disorders Nausea	15.4% 2/13 • Number of events 2
Gastrointestinal disorders Oral cavity Mucositis/stomatitis (clinical exam)	15.4% 2/13 • Number of events 3
General disorders Fatigue	69.2% 9/13 • Number of events 63
General disorders Fever	7.7% 1/13 • Number of events 1
General disorders Pain	7.7% 1/13 • Number of events 6
Infections and infestations Infection without neutropenia	7.7% 1/13 • Number of events 1
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 2
Infections and infestations Urinary tract infection	7.7% 1/13 • Number of events 1
Injury, poisoning and procedural complications Bruising	7.7% 1/13 • Number of events 5
Investigations Bilirubin	7.7% 1/13 • Number of events 1
Investigations Leukopenia	76.9% 10/13 • Number of events 64
Investigations Lymphocyte count decreased	7.7% 1/13 • Number of events 5
Investigations Neutrophil count decreased	76.9% 10/13 • Number of events 62
Investigations Platelet count decreased	76.9% 10/13 • Number of events 74
Metabolism and nutrition disorders Hyperglycemia	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • Number of events 4
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 1/13 • Number of events 7
Respiratory, thoracic and mediastinal disorders Pulmonary	7.7% 1/13 • Number of events 9
Skin and subcutaneous tissue disorders Alopecia	7.7% 1/13 • Number of events 3
Skin and subcutaneous tissue disorders Hand-foot skin reaction	15.4% 2/13 • Number of events 2
Skin and subcutaneous tissue disorders Rash	53.8% 7/13 • Number of events 8
Vascular disorders Hypertension	30.8% 4/13 • Number of events 13

Additional Information

Dr. Shaji Kumar

Mayo Clinic

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place