Treatment Of Multiple Myeloma Pts Research Articles

Update of a Phase II Study of Lenalidomide-Elotuzumab As Maintenance Therapy Post-Autologous Stem Cell Transplant (AuSCT) in Patients (Pts) with Multiple Myeloma (MM)

Update of a Phase II Study of Lenalidomide-Elotuzumab As Maintenance Therapy Post-Autologous Stem Cell Transplant (AuSCT) in Patients (Pts) with Multiple Myeloma (MM)

Primary Results from the Phase 3 Tourmaline-AL1 Trial of Ixazomib-Dexamethasone Versus Physician's Choice of Therapy in Patients (Pts) with Relapsed/Refractory Primary Systemic AL Amyloidosis (RRAL)

Primary Results from the Phase 3 Tourmaline-AL1 Trial of Ixazomib-Dexamethasone Versus Physician's Choice of Therapy in Patients (Pts) with Relapsed/Refractory Primary Systemic AL Amyloidosis (RRAL)

Updated Results of a Phase II Study of Lenalidomide-Elotuzumab As Maintenance Therapy Post-Autologous Stem Cell Transplant (AuSCT) in Patients (Pts) with Multiple Myeloma (MM)

Background: Lenalidomide (LEN) monotherapy has been effective in extending progression free survival (PFS) after myeloablative AuSCT in pts with MM. Elotuzumab (ELO), a humanized IgG1 immunostimulatory monoclonal antibody against signaling lymphocytic activation molecule F7 (SLAM F7), is FDA approved in combination with LEN and dexamethasone (DEX) for treatment of MM pts who have received 1-3 prior therapies. The objective of this phase 2 trial is to evaluate the efficacy and safety of adding ELO to LEN as maintenance therapy post-myeloablative AuSCT. We report updated results of the primary (PFS) and secondary (overall survival [OS] and toxicity) endpoints. Patients and Methods: Between 4/15/2015-1/27/2016, 27 evaluable pts were treated on 28 day cycles with ELO, 10 mg/kg iv weekly for cycles 1-2, q2weeks for cycles 3-6, then 20 mg/kg once monthly for cycles 7+. Pts enrolled after 1/28/2016 (n=57 pts) have received ELO, 10 mg/kg IV weekly for cycles 1-2, and 20 mg/kg on day 1 from cycle 3 until disease progression (PD). LEN has been dosed at 10 mg/day for cycles 1-3, with a dose increase to 15 mg/day at physician discretion starting with cycle 4, in the absence of non-hematologic toxicity > grade 1 and significant cytopenias (ANC The study9s primary endpoint is PFS, defined as time from AuSCT to PD or death (whichever occurs first), or time of last contact. Secondary objectives are best response, OS, incidence of second primary malignancies (SPMs) and adverse event (AE) profile. Total enrollment of 100 pts is planned. Patients are followed until death, withdrawal of consent or removal from study. Eligible pts received ≤2 lines of induction therapy, and are 60-210 days post-AuSCT. Results: Pts (n=84) have been treated for a median of 16 cycles (2-43). At study entry, 27 (32%) had complete response (CR), 36 (43%) had very good partial remission (VGPR), 20 (24%) had partial remission (PR) and 1 (2%) had minor remission (MR). Best response achieved to date on study is CR in 44 pts (52%), VGPR in 31 pts (37%) and PR in 9 pts (11%). For those who have converted to CR on study, median time to CR was 2 months. Of 22 pts in CR who have been tested for minimal residual disease (MRD) to date, 20 are negative by flow cytometry (minimum of 2 million cells evaluated). Three of 20 have converted from VGPR to MRD negativity while on study. With a median follow up of 23 months, 96% of pts (n=81) remain alive. Ten pts have had PD; of these, 6 had high risk cytogenetics. Two died of PD while receiving salvage therapy. One additional pt died on study in VGPR, after developing acute cerebral encephalopathy with refractory status epilepticus of unclear etiology. Four pts withdrew for personal reasons, 4 were removed at physician discretion (prolonged cytopenias [1], drug rash [1], worsening memory impairment [1], therapy related myelodysplastic syndrome (t-MDS) [1]), and 2 lost insurance coverage. Estimated 3 year PFS is 81%. High risk cytogenetics adversely affected PFS (p=0.02). Grade 3-4 Hematologic AEs (no. of pts) were: neutropenia 32% (27), febrile neutropenia 15% (13), thrombocytopenia 8% (7), and anemia 7% (6). Grade 3-4 non-Hematologic AEs (no. of pts): respiratory infections 17% (15), diarrhea 14% (12), fatigue 13% (11), other infections 8% (7), peripheral neuropathy 7% (6), myalgias 6% (5), nausea/vomiting 4% (3), dizziness 2% (2), memory impairment 2% (2), maculopapular rash 2% (2), edema 1% (1). SPMs include intra-epidermal adenocarcinoma of the neck (1), mucinous appendiceal neoplasm (1), t-MDS (1), prostate cancer (1), and melanoma (1). Renal cell carcinoma was diagnosed in 1 pt, 15 months after removal from study for PD. Conclusions: Lenalidomide-elotuzumab is a well-tolerated maintenance therapy during which 33% of 84 pts had improvement in quality of response while on therapy, including 20% who converted to CR. The number of pts experiencing improvement may be underestimated due to ELO interference with paraprotein measurement on electrophoretic studies. Additional follow up is required to determine if the improved quality of responses translate into improvements in PFS and OS. Available data supports conduct of a Phase 3 trial. Disclosures Thomas:Array Pharma: Research Funding; Amgen Inc: Research Funding; Bristol Myers Squibb Inc.: Research Funding; Acerta Pharma: Research Funding; Celgene: Research Funding. Shah:Karyopharm Therapeutics: Employment. Lee:Celgene: Consultancy, Membership on an entity9s Board of Directors or advisory committees; Adaptive Biotechnologies Corporation: Consultancy; Amgen: Consultancy, Membership on an entity9s Board of Directors or advisory committees; Chugai Biopharmaceuticals: Consultancy; Takeda Oncology: Consultancy, Membership on an entity9s Board of Directors or advisory committees; Kite Pharma: Consultancy, Membership on an entity9s Board of Directors or advisory committees. Patel:Abbvie: Research Funding; Celgene: Research Funding; Takeda: Research Funding; Poseida Therapeutics, Inc.: Research Funding.

A Phase 1/2 Trial of Pomalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin for Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

BackgroundImmunomodulatory drugs (IMiD), such as thalidomide and lenalidomide (LEN) and its newest derivative pomalidomide (POM), have shown great promise for the treatment of multiple myeloma (MM) patients (pts). POM has in vitro anti-MM potency and has shown efficacy for the treatment of relapsed/refractory (RR) MM pts. POM with dexamethasone (DEX) induces responses even for MM pts who are refractory to bortezomib (BORT) and LEN (Richardson et al, 2012). Pegylated liposomal doxorubicin (PLD) with BORT is FDA-approved for the treatment of MM pts who have received one prior therapy not containing BORT. The combination of PLD and LEN or thalidomide has shown efficacy for both RR and frontline MM pts (Offidani et al, 2006; 2007). We have also demonstrated that both the efficacy and tolerability of LEN in combination with DEX, PLD and BORT (DVD-R) may be improved by changing the doses and schedules of these drugs (Berenson et al, 2012). Based on these results, we hypothesized that the combination of POM, DEX and PLD would be effective for the treatment of RRMM pts. Thus, we conducted the first study investigating the safety and efficacy of POM in combination with intravenous (IV) DEX and PLD as a phase 1/2 trial using a modified dose, schedule and longer 28-day cycles for pts with RRMM.MethodsThe phase 1 portion enrolled MM pts w/progressive disease whereas those enrolled in phase 2 also had to be refractory to LEN (single-agent or in combination), as demonstrated by progressive disease while receiving their last LEN-containing regimen or relapsed within 8 weeks of their last dose of this IMiD. Pts who previously received POM treatment were ineligible. POM was administered orally on days 1-21 of a 28-day cycle, while DEX (40 mg) and PLD (5mg/m2) were both infused on days 1, 4, 8, and 11. During phase 1 enrollment, three cohorts were enrolled at 2, 3 and 4 mg doses of POM, and DEX and PLD were both administered at fixed doses. Phase 2 enrollment commenced once the MTD was established from the phase 1 portion of the study.ResultsAs of August 1, 2015, 70 pts were screened, 68 were enrolled in the trial (with the pre-planned enrollment goal reached) and had received study drug, and a total of 50 pts were evaluable for safety and efficacy. Among all enrolled pts, 60pts discontinued treatment and 8 remain active. Pts had received a median of 4 prior treatments (range 1-18). Median number of cycles for all pts was 4 (range 1-8), with a median follow-up time of 5.5 months (range 0-22).During the phase 1 portion of the trial, the maximum tolerated dose (MTD) of POM was established at 4 mg. Enrollment of pts into the phase 2 portion of the trial began at the MTD. However, neutropenia ≥ grade 3 was observed at this dose in 10/17 (58.8%) phase 2 pts; and, as a result, the protocol was amended so that the MTD was lowered to 3 mg for all pts subsequently enrolled.Among the 57 pts enrolled in phase 2, 53% percent were refractory to LEN and steroids with or without other agents and 31% had previously received PLD. A median of 4 cycles (range, 1 to 8) were administered among the pts enrolled in phase 2. Fifty-five pts were evaluable for response as 2 pts are active but have not yet had any post-baseline disease assessment. Among all evaluable pts (n=55) enrolled in phase 2, the overall response rate (ORR) was 33% (CR= 5%, VGPR= 5% and PR=23%) and clinical benefit rate (CBR) was 47% with 11 pts (26%) showing stable disease and 5 pts (12%) demonstrating progressive disease. For all evaluable pts enrolled in phase 2, the median follow-up time was 3.6 months (range 0-12 months) and the median PFS was 4.2 months (range 0.3- 29.0+). ORR and CBR for pts in the phase 2 were higher among pts receiving POM at 3 mg (36% and 51%, respectively) than among pts receiving POM at 4 mg (25% and 37%, respectively). Pts receiving the 4 mg dose of POM experienced more toxicities resulting in discontinuations, which likely explains the lower ORR and CBR observed among pts receiving this POM dose.Common ≥ grade 3 adverse events observed throughout the trial were neutropenia (49 pts; 72.0%), lymphopenia (36 pts; 52.9%), leukopenia (33 pts; 48.5%), hyponatremia (27 pts; 39.7%), and hypokalemia (26pts; 38.2%). One pt died of grade 5 sepsis.ConclusionsThis phase 1/2 trial is the first evaluating POM with PLD and DEX and demonstrates that the combination of POM at 3 mg, PLD and DEX using a modified 28-day cycle schedule is safe and effective for the treatment of MM pts refractory to LEN. DisclosuresNo relevant conflicts of interest to declare.

A Phase 1/2 Trial of Pomalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin for Patients with Relapsed/Refractory Multiple Myeloma

BackgroundImmunomodulatory drugs (IMiD), such as thalidomide and lenalidomide (LEN) and its newest derivative pomalidomide (POM), have shown great promise for the treatment of multiple myeloma (MM) patients (pts). POM has in vitro anti-MM potency and has shown efficacy for the treatment of relapsed/refractory (RR) MM pts. POM with dexamethasone (DEX) induces responses even for MM pts who are refractory to bortezomib (BORT) and LEN (Richardson et al, 2012). Pegylated liposomal doxorubicin (PLD) with BORT is FDA-approved for the treatment of MM pts who have received one prior therapy not containing BORT. The combination of PLD and LEN or thalidomide has shown efficacy for both RR and frontline MM pts (Offidani et al, 2006; 2007). We have also demonstrated that both the efficacy and tolerability of LEN in combination with DEX, PLD and BORT (DVD-R) may be improved by changing the doses and schedules of these drugs (Berenson et al, 2012). Based on these results, we hypothesized that the combination of POM, DEX and PLD would be effective for the treatment of RRMM pts. Thus, we conducted the first study investigating the safety and efficacy of POM in combination with intravenous (IV) DEX and PLD as a phase 1/2 trial using a modified dose, schedule and longer 28-day cycles for pts with RRMM.MethodsThe phase 1 portion enrolled MM pts w/ progressive disease whereas those enrolled in phase 2 also had to be refractory to LEN (single-agent or in combination), as demonstrated by progressive disease while receiving their last LEN-containing regimen or relapsed within 8 weeks of their last dose of this IMiD. Pts who have previously received POM treatment were ineligible. In the phase 1 portion, POM was administered at 2, 3 or 4 mg daily in three cohorts on days 1-21 of a 28-day cycle and DEX (40 mg) and PLD (5 mg/m2) were fixed and given intravenously on days 1, 4, 8, and 11.ResultsAs of June 20th, 2014, 48 pts were enrolled in the trial and a total of 47 pts had received study drug. Pts had received a median of 4 prior treatments (range 1-18), with a median of 2 prior IMiD-containing regimens (range, 0-8). Fifty-three percent of the pts had received a prior PLD-containing regimen and 21% had received a prior IMiD and PLD combination treatment. Among all enrolled pts, 40 pts discontinued treatment and seven remain active. Pts completed a median of 3 cycles (range: 1-8), with a median follow-up time of 5.4 months (range: 0-22).During the phase 1 portion of the trial, the maximum tolerated dose (MTD) of POM was established at 4 mg. Enrollment of pts into the phase 2 portion of the trial began at the MTD. However, neutropenia ≥ grade 3 was observed at this dose in 10/17 (58.8%) phase 2 pts; and, as a result, the protocol was amended so that the MTD was lowered to 3 mg for all pts subsequently enrolled.Among the 36 pts enrolled in phase 2, 78% percent were refractory to LEN and steroids with or without other agents and 47% had previously received PLD. A median of 2 cycles (range, 1 to 8) were administered among the pts enrolled in phase 2. Thirty-five pts were evaluable for response as one pt was active but had not yet had any post-baseline disease assessments. Among all pts enrolled in phase 2, the overall response rate (ORR) and clinical benefit rate (CBR) were 29% and 49%, respectively, with 6 pts (17%) showing stable disease and 12 pts (34%) demonstrating progressive disease. For all pts enrolled in phase 2, the median follow-up time was 4.7 months (range 0-12) and the median PFS was 5.3 months.ORR and CBR for pts in the phase 2 were higher among pts receiving POM at 3 mg (32% and 58%, respectively) than among pts receiving POM at 4 mg (25% and 37%, respectively). Pts receiving the 4 mg dose of POM experienced more toxicities resulting in discontinuations, which likely explains the lower ORR and CBR observed among pts receiving this POM dose.Common ≥ grade 3 adverse events observed throughout the trial were neutropenia (21 pts; 44.7%), lymphopenia (10 pts; 21.3%), and hyponatremia (4 pts; 8.5%). One pt died of grade 5 sepsis.ConclusionsThis phase 1/2 trial is the first evaluating POM with PLD and DEX and demonstrates that the combination of POM at 3 mg, PLD and DEX using a modified 28-day cycle schedule is safe and effective for the treatment of MM pts refractory to LEN. DisclosuresBerenson:Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau. Swift:Celgene: Consultancy, Honoraria. Vescio:Celgene: Honoraria.

A Retrospective Study to Evaluate the Incidence and Severity of Peripheral Neuropathy for Relapsed/Refractory Multiple Myeloma Patients upon Retreatment with Bortezomib

Background: Peripheral neuropathy (PN) is associated with multiple myeloma (MM) and often worsened with thalidomide (THAL) and vincristine (VCR) therapy. Bortezomib (BTZ) is a proteasome inhibitor approved for the treatment of MM that has been also shown to cause PN. An increased risk of BTZ-induced PN has been associated with the presence of both PN and diabetes mellitus (DM) before treatment. However, the incidence and characteristics of BTZ-induced PN among MM patients (pts) retreated with another BTZ-containing regimen is unknown. We analyzed the incidence, severity and risk factors for PN after treatment of MM pts with a second BTZ-containing regimen.Methods: Retrospective chart analysis. MM pts that had progressed from at least one prior BTZ-containing regimen and had received treatment with another BTZ-containing regimen were eligible. Pts had to have experienced PN during the course of the first BTZ regimen and could not have received therapy with THAL or VCR. The protocol was later amended to allow inclusion of pts without PN during their first BTZ treatment and those who had received THAL or VCR. Statistical significance was assessed using Fisher’s or McNemar’s tests as appropriate. The relationship between comorbidities, prior THAL or VCR treatment and PN grade after BTZ treatment and re-treatment was analyzed using a multivariate logistics regression model. All statistical analyses were two-sided and were performed at the 0.05 level of significance.Results: As of July 3, 2014, 83 pts have been accrued to the retrospective analysis, and 58 chart reviews have been completed. The median age of pts included in the analysis was 64 years (range: 31-84 years); 57% of the pts were male and 69% were Caucasian. Pts had received a median of 2 prior regimens (range: 2-10); 43% of the pts had received prior regimens containing THAL and 15% of those had also received therapy with VCR. Prior to the protocol amendment, the eligibility criteria required pts to have experienced PN after the first BTZ treatment; therefore, most pts included in this analysis (88%) had PN.During their first BTZ treatment, the most severe grade of PN experienced by the majority of the pts was grade 1 (N=34), followed by grade 2 (N=13) and grade 3 (N=4). A comparison of the symptoms assessed when pts had their most severe grade of PN during this treatment and the severity reported at its onset showed that PN worsened in only 16% of pts. Nearly half (48%) of pts showed no change in PN whereas symptoms improved or resolved in 15% and 9% of the pts, respectively. During treatment with the second BTZ-containing regimen, a comparable proportion of pts (N=44; 76%) reported having experienced PN. Among those experiencing PN upon re-treatment, the most severe grade of PN experienced by the majority of the pts (N=29) was also grade 1, followed by grade 2 (N=12) and grade 3 (N=3). During the second BTZ treatment, a comparison of the symptoms that pts had when PN was at its worst and those recorded at its onset demonstrated that PN worsened in only 7% of the pts. PN showed no change in 47%, improved in 15%, or resolved in 7% of the pts.Interestingly, 17% of the pts (N=10) who had reported PN while receiving their first BTZ-containing regimen did not report this complication during their second BTZ treatment, while 7% of the pts (N=4) experienced PN only upon re-exposure. There was no association between the incidence of PN during the first BTZ treatment and its incidence during re-treatment (p=0.1213) or between the severity of PN (defined as worsening vs. not worsening) after first BTZ treatment and its severity after BTZ re-exposure (p=0.1306).Fifty-four percent of the pts presented with comorbidities, including DM (26%), hypertension (HTN, 22%) and peripheral vascular disease (PVD, 13%). There were no associations between PN grade after BTZ treatment and prior THAL or VCR exposure (p=0.5569) or between PN grade and comorbidities (DM, p=0.6657; HTN, p=0.9966; PVD, p=0.9966). Similar results were found for BTZ re-exposure (THAL or VCR, p=0.8672; DM, p=0.4137; HTN, p=0.2033; PVD, p=0.9954).Conclusions: Results from this retrospective study show that the severity and incidence of PN did not change with a second BTZ-containing regimen. Comorbidities or prior therapy with other PN-inducing agents such as THAL or VCR did not significantly increase the risk of PN after BTZ re-treatment. Enrollment into the study continues and updated results will be presented at the meeting. DisclosuresBerenson:Millennium: Consultancy, Honoraria, Research Funding, Speakers Bureau. Tabbara:Millennium: Speakers Bureau. Lutzky:Millennium: Speakers Bureau. Ailawadhi:Millennium: Consultancy. Moezi:Millennium: Speakers Bureau.

Perifosine Plus Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients Previously Treated with Bortezomib: Final Results of a Phase I/II Trial

Perifosine Plus Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients Previously Treated with Bortezomib: Final Results of a Phase I/II Trial

Phase II Trial of Lenalidomide, Bortezomib, and Dexamethasone In Patients (pts) with Relapsed and Relapsed/Refractory Multiple Myeloma (MM): Updated Efficacy and Safety Data After >2 Years of Follow-up

Phase II Trial of Lenalidomide, Bortezomib, and Dexamethasone In Patients (pts) with Relapsed and Relapsed/Refractory Multiple Myeloma (MM): Updated Efficacy and Safety Data After >2 Years of Follow-up

A Randomized Comparison of Dexamethasone + Thalidomide (Dex/Thal) vs Dex + Placebo (Dex/P) in Patients (pts) with Relapsing Multiple Myeloma (MM).

We randomly compared a Dex/Thal and a Dex/placebo combination as treatment of MM pts in first or second relapse after high dose therapy (HDT) or conventional chemotherapy (CCT). 116 pts, aged 41 to 81 (med. 63 yrs), were enrolled between July 2001 and December 2004. Dex was given orally during 4 days at a dose of 40 mg/day every other week for 4 cycles and then monthly. Thal or placebo were given blindly at the initial dose of 100 mg, escalated up to 400 mg daily according to tolerance, and maintained for a maximum of 12 mths. In both arms, treatment initially included continuous infusions of Doxorubicin (9 mg/m2/d for 4 days 4–5 wk apart). In July 2002, because of a high incidence of thrombotic event (TE), the study was interrupted during a six-mth period, before restarting without Doxorubicin administration. Anticoagulation prophylaxis wasn't systematically given at any time.Main characteristics of pts included in both arms were similar, including age above 65 yrs (43% in the Dex/Thal arm, 44 % in the Dex/P arm), previous therapy (HDT 57% vs 56%), MM isotype (IgA: 26% vs 21%), serum β2m (≥3 mg/L, 48% vs 55%), serum creatinine (≤ 300 μmol/L in all pts) and albumin levels. Data were analyzed in an intent to treat basis, regarding EFS as the primary objective.A partial response (defined by a 50% or more reduction of MM protein in serum) was achieved in 46% of all pts, in 65% of pts treated by Dex/Thal and in 28% of pts treated by Dex/P (p<.0001). At one year post randomization, 46.5% of pts in the Dex/Thal arm were alive and free of progression, compared to 31% in the Dex/P arm (p=.009). Death rates were 7% (n=4) and 5% (n=3), respectively.Median dose of actually tolerated Thal was 150 mg daily. At least one ≥ grade II WHO adverse event was reported in 90% of pts who received Thal, as compared with 42% of pts who received the placebo (p<.0001). A TE was recorded in 12 (22%) of pts in the Dex/Thal arm, as compared to 4 (7%) of pts in the Dex/P arm (p= .02). Other frequent side effects were somnolence/mood changes (58% vs 21%), constipation/nausea (43% vs 11%), skin/mucosal dryness (26% vs 9%) and tremor (19% vs 4%). A symptomatic peripheral neuropathy was observed in 28% and 7% of pts, respectively. Besides the 25 pts who completed the trial (16 and 9 in both arms, respectively), toxicity was the main cause of treatment discontinuation in 21 (55%) pts of the Dex/Thal arm and in 3 (6%) pts of the Dex/P arm.This randomized study demonstrates that the adjunction of Thal to Dex, although it increases toxicity, is a valuable therapeutic option for pts with relapsing MM since it produces higher response rate and longer remission duration than Dex alone.

Treatment of patients with ibandronate and correlation with serum carboxy-terminal telopeptide of type I collagen levels

6734 Background: Ibandronate (IB) is found to reduce, significantly, the occurrence of osteolytic bone lesions in a murine model of myeloma bone disease. The carboxy-terminal telopeptide of type I collagen (ICTP) is a serum marker of bone metastasis in patients (pts) with solid tumors and can be used as a serum marker of bone metabolism in multiple myeloma (MM). Methods: Sixteen MM pts with osteolytic lesions, 6 M and 10 F, with a median age of 72 years (range 47–86 ) were treated with IB at a dose of 4 mg, administrated by IV infusion over 1 hour, every 4 weeks for at least 12 months. Pts were clinically evaluated before, during and after IB administration for possible occurrence of side effects. Routine serum chemical screening including beta-2 microglobulin (β2-m), calcium and alkaline phosphate and radiographic evaluation of osteolytic lesions were performed during the study. Serum samples were taken before each IB administration and stored frozen until used for measurement of ICTP levels with b-CrossLaps/serum immunoassay. Results: Clinical improvement of skeletal pains was observed after the first cycle of IB treatment. There were no major side effects after IB administration. Haematologic, hepatic or renal dysfunction were not detected except for transient hypocalcaemia and hypophosphataemia in 5 pts (31%). High mean serum ICTP levels were documented only in 3/16 pts ( 1,513 ± 0,31 ng/ml ) while the remainder of pts had levels within normal limits ( 0,392 ± 0,31 ng/ml). High serum ICTP levels were correlated with progressive osteolytic bone disease and elevated serum levels of β2-m, hypercalcaemia, bad performance status and stage of disease. Treatment with IB, in these fore mentioned 3 pts, resulted in reducing the high ICTP levels in normal limits even after the first cycle of treatment (pre: 1,513 ± 0,31 ng/ml, post: 0,881 ± 0,38 ng/ml ). If the decrease of serum ICTP levels caused by IB treatment is confirmed, in future trials, with a greater number of pts, serum ICTP levels can be used as a prognostic index in MM. Conclusions: Treatment of MM pts with osteolytic lesions with ΙΒ is well tolerated and probably may decrease serum ICTP levels. No significant financial relationships to disclose.